Eligiblility for Pharmacovigilance career

 

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Officer / Executive - Regulatory Affairs ( API )-Sun Pharmaceutical Industries Ltd

 

Job Description

1. Preparation & Compilation of DMF for emerging markets (countries in region of CIS/Asia, Middle east/N. Africa/S.Africa & LATAM) in coordination with plant regulatory affairs.

2.Review and compilation of all the documents received from plant, R&D and other departments as per regulatory requirement

3.Preparation of anticipated queries based on compilation and current query trend.

4. Review and response to the deficiencies received from regulatory authorities/Customers.


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Opening for Rave Programmer Candidates (2-6 yrs) Quintiles 2 - 6 yrs Bengaluru/Bangalore

Dear Candidates,

Looking for experienced candidates in Rave Programming with 2 to 6 years of experience.

RESPONSIBILITIES :-
Development of eCRF to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting. Understand Quintiles EDC processes and the requirements on the design for reporting and study management.
Interprets the study protocol.
Advise and provide justification for design decisions to Principal Programmer and at multiple Design Meetings.
Responsible for optimal design reducing the number of edit checks required, ensuring good system performance, and the utilization of global/client specific libraries to ensure consistency and efficiency.
Facilitates the Internal Edit Check Specification Review Meeting and leads the discussions regarding the Edit Specifications document.
Requires good communication skills and this role will work closely with the Study DTL, Validation team lead (VTL) and Principal Programmer.
Requires a technically logical thinker to resolve questions and issues with the Principal Programmer, DTL and VTL. This role will need to have a good knowledge of forms design, data flow, and the impact of design on the system.
Presentation and negotiation skills with internal and external customers.
Communicates any project risks to the DTL, including the potential for missing a timeline in the Data Management Project Plan
Ensures the completion and documentation of all project-specific training, as well as staying current with required SOP reading
Reviews build timelines and provide inputs.
Reviews budget for own projects, identify out of scope activities if any and inform relevant parties.
Take part in post production change requests.
Understand and implement new tools and technologies of the EDC vendor (preferably Medidata).

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Urgently Required- Pharmacist - Fresher most Welcome- Bengaluru/Bangalore , Mumbai , Pune

2,75,000 - 7,50,000 P.A. + TA , DA +HRA + Conveyance

Completes pharmacy operational requirements by organizing and directing technicians' work flow; verifying their preparation and labeling of pharmaceuticals; verifying order entries, charges, and inspections.  


We are urgently hiring the Male & Female Fresher candidate .Immediately Send your resume to our company email address - career@accentureconsultancy.com

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Start your Pharmacovigilance Career- A stable and promising Career

Pharmacovigilance the drug safety it can be defined as the study and prevention of adverse effects caused by pharmaceutical products. Pharmacovigilance is the reason that many drugs are withdrawn from or not even brought into the market at times.
Our national health policy supports and helps to create more awareness about pharmacovigilance as their primary goal is to ensure students of medicine are aware of the adverse effects of certain pharmaceuticals. Pharmacovigilance makes it possible to implement quality systems in all pharmaceutical companies that manufacture large amounts of medicine.

Pharmacovigilance Courses

Training in pharmacovigilance is done by an expert international and national faculty with years of experience in the practical and theoretical aspects. All the study materials and course content are developed in a way that helps students to get the quality knowledge, exactly what is required to work into the industry as well as to prepare well for interview.

You may be eligible for a course in pharmacovigilance, if you are any one of the following:

• Graduate in Pharmacy and Bio-Sciences (final year students are also eligible)
• Medical Professional i.e Doctor of all disciplines
• Graduate in pharmacy and bio-sciences
• Junior professional in Pharmaceutical industry, IT Industry and Clinical Research Organisations.

Pharmacovigilance Salary

A job holder in this field can easily get the starting salary of Rs.3.5 - Rs.8 lakhs P.A..As more recognition is given to drug safety all over the world,jobs in India in this field are increasing in number. Hiring process are very much selective to candidates educational qualification, back ground knowledge, knowledge over drug development / pharmacovigilance area, communication skill and experience as applicable for different positions.

Pharmacovigilance Job Prospects

There is no shortage of jobs in this field as high-quality pharmacovigilance practice makes for good business dealing. Students in this field can get jobs in various pharmaceutical companies, bio-tech companies, medical device and IT Life Science KPO & BPO,Clinical Research Organisations (CRO), can earn attractive and handsome packages.With new drugs being made every day, a career in pharmacovigilance has promising prospects.

Pharmacovigilance Eligibility Criteria

To pursue a career in pharmacovigilance, the minimum eligibility criteria to apply for the program is:

• A postgraduate or graduate degree in Bio Science/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech)
• A postgraduate or graduate degree with Chemistry as a subject
• A postgraduate or graduate degree in Pharmacy or Pharmaceutical Sciences, PharmD
• A postgraduate or graduate degree in Medicine

The selection process is based on merit.

Pharmacovigilance Scholarships

This program offers scholarship to every students based on merit. The Scholarship is offered based on the overall performance of the students from 10th level to last educational qualification examination (% of marks).

Pharmacovigilance Duration & Venue

The course takes student admission twice in a month . The first batch intake starts from 1st-10th of a month and second batch starts from 15-20th of a month.The number of admissions to each batch is limited, so that personal attention can be paid to each student, and this will also facilitate effective discussions and project oriented training during the course of study. Students and working professionals can do the program program from anywhere. Classes are in e-learning mode, where lectures will be provided over online environment in flexible timings (7-9am, 3-5pm and 8-10pm). Students can schedule their class day and time wise. Effective days of training are taken on the basis of no. of class.

Pharmacovigilance Fees

The total fees for 2 to 6 month course will be Rs.7,000 to 20,000 for working Indian Professionals and SAARC countries. The fees will cover all course materials, tution and examination fees.

Pharmacovigilance Examination

At the end of program students will be assessed on how well they have understood the course material. The exams will consist of:

• e-Exams written section consisting of multiple choice and semi-long question
• A Viva: 30 minutes long
• A short project to be submitted at the end of the course on the topics to be given by the Faculty on Pharmacovigilance

MORE ABOUT THE PROGRAM, FEES, DURATION and PLACEMENT ASSISTANCE.
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Clinical Trials -What is that?

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to

• Make sure that the study is ethical
• Protect the rights and welfare of the participants
• Make sure that the risks are reasonable when compared to the potential benefits

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Drug Safety Physician / Medical Reviewer - Synowledge PV Services India Pvt Ltd

JOB TITLE: Drug Safety Physician/ Senior Drug Safety Physician

LOCATION: Mysore, India

YEARS OF EXPERIENCE: 0-5 years experience in PV

EDUCATION: MBBS/ MD (Any)

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

As a Medical Reviewer

Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
Determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Acquire and maintain knowledge of applicable Global Health Authority regulations
Perform any other drug safety related activities as assigned
Participate in internal and external audits and inspections by clients and health authorities
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Openings for Freshers- Pharmacovigilance

Dear Candidate,

Looking for freshers who has completed their graduation B.Pharma/M.Pharma/ BDS/ M.Sc/B.Tech.

Quintiles is the worlds leading provider of biopharmaceutical services. With a network of 29,000 employees conducting business in approximately 100 countries, Quintiles has helped develop or commercialize all of 2013s top 100 best-selling products or compounds. Using our extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.

RESPONSIBILITIES
Provide intake and tracking of initial safety and clinical event validation and adjudication (CEVA) data. Transfer incoming
safety/CEVA data to project team. Identify any problems with incoming faxes and bring them to the attention of the senior
team member.
Distribute safety data to marketing authorization holders, customers, regulators and investigators.
Specific project responsibilities include set-up and/or maintenance of safety/CEVA files for reported events; archiving of
files when closed; coordination of transfer of archived material to company/customer archive storage facilities;
preparation and assistance in setting-up and updating project files; maintenance of personal safety files for mail merges
and regulatory documents; where required, data entry of events into tracking database and assistance of transfer of
events to customers.
Provide administrative support for the department by coordinating team/department/customer meetings, coordinating
stationery orders, dispatching data via courier services, reserving meeting rooms and IT equipment; and providing
secretarial support as required.
Generate and distribute alert letters.
Identify and record quality problems and bring them to the attention of a senior team member.
Provide training/mentoring new/less experienced staff.
Assist project lead and CEVA management with specific aspects of CEVA processes.
Set up and maintain Serious Adverse Event (SAE) files for reported events; organize and send files for archive when
events are closed.
Coordinate, schedule and submit reports to regulatory authorities in accordance with deadlines.
Coordinate distribution of safety letters to study investigators and Clinical Research Associates.
Assist in processing incoming and outgoing Adverse Event (AE) reports by collecting and tracking incoming AE reports
sent via fax, email, eCRF, etc; determining initial/update status of incoming events; tracking timelines for completion of
AE processing; performing data entry into safety database; routing report information to appropriate PhV project
personnel in the workflow for continued processing; performing quality control activities as directed by project lead or
manager; generating established safety data reports; submitting AE reports to client and other project team members
identified by project lead; obtaining confirmation of report receipt and track submission; and assuming workflow
responsibilities for local and global projects.
Perform records management tasks such as creating and tracking case folders for AE reports; filing, retrieving and
delivering case folders; assisting in maintenance of document control room and relevant applications/systems as directed
by manager; archiving case folders and project files; assisting in creation of PhV records management processes and
procedures; providing key input to management on acquisition and/or upgrade of records management
application/systems; and serving as liaison between Pharmacovigilance department and records management
department.
Assist with system support tasks such as utilizing design specifications, AE form, and protocol, creating projectspecific
entry specifications and annotated AE forms for safety database with direction from project lead and/or manager;
creating project tracking spreadsheets and associated tracking entry specifications; assisting in database validation
through performance of user testing; performing ad hoc database searches for project team leads; assisting project lead
in assessing database setup needs; and assisting with assuring systems issues are reported and resolved.
Perform additional project-related and administrative tasks such as handling investigator mailings including creation of
labels using investigator list, copying of documents, envelope stuffing, and tracking and filing of submitted materials;
creating and maintain project files; working with project lead to develop project instructions; performing reconciliation
between the safety and clinical databases; distributing AE listings to client and/or project team members; performing
project start-up tasks; providing project metrics to management; and assisting with data entry, workflow and deadline
quality measurements.
Participate in continuous improvement of all departmental processes and procedures.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Basic knowledge of ICH and GCP
Basic knowledge of medical terminology if processing
Good understanding of Core Operating Procedures (COPs)
Word processing and data entry skills
Strong organizational skills and time management skills
Flexibility and excellent verbal and written communication skills
Ability to deal successfully with many internal clients competing for attention, services and resources
Good attention to detail and accuracy
Ability to establish and maintain effective working relationships with co-workers, managers and colleagues.
Highly motivated and organised with a flexible attitude
Ability to follow instructions/guidelines, utilize initiative and work independently
Ability to establish and maintain effective working relationships with coworkers, managers and clients

Regards,

Kavya 

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Real-Time Decision-Making: How Quintiles Accelerates Trial Conduct with Fast, Easy Access to Data

Today’s pharmaceutical and clinical research companies generate a previously unimaginable trove of real-world data to determine the validity of their clinical trial decisions. Quintiles, the global leader in contract research trials, is currently running clinical trials, phases 1 through 4, in over 60 countries – requiring access to need-to-know information anywhere, anytime.
With the market-leading Oracle Health Sciences InForm EDC platform, all stakeholders are now able to meet the challenges of how to maximize the value of data resources to determine how to help sponsors get their products to market as quickly as possible.

Highlights include:

• Quintile’s perspective on the changing market landscape
• The challenges of using real-world evidence in R&D and commercialization
• Demonstrating value through real-time decision-making

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Officer Pharmacovigilance Wipro BPS (A division of Wipro Limited)-Delhi-opportunity for fresher

Dear Candidate, 

Wipro BPS is hiring for Pharmacovigilance Business. 

Please find the JD below, if interested please walk-in to the below address with the required documents.

Address: A-23, Mathura Road, Sarita Vihar (Near Sarita Vihar Metro Station)

Walk-in date: 27th Oct 2015

Walk-in Time: 1pm - 4 pm

Contact Person: Bipasha Bose

Qualification: Education: Bachelors / Masters in Pharmacy Registered Pharmacist

Valid PAN CARD available

0 - 1 year experience

Skills:

Excellent English Communication both written and Spoken

Performing preliminary step of Pharmcovigiliance that case intake

Doing research work on adverse events or product complaints, or with an inquiry about the human health product

Receiving calls from consumers and health care professionals with reports

Verbal Probing for necessary information including but not limited to the adverse event(s), the patient's medical history, Suspect product, concomitant drugs involved if any, and medication history of patient

Answering to the inquiries, and respond to inquiries in a knowledgeable manner

Completing various safety reports regarding the contact through computer based database system

Receiving adverse drug reaction or adverse event information Medical coding of terms according to Med DRA. WHO medical dictionary Filling AEM (Adverse event management) forms and generating adverse event reports according to ICH-guidelines E2A, E2B, E2E Writing narratives for adverse events

Ability to work under pressure and deliver

Comfortable working in Voice Process

Comfortable with night shifts

Immediate Joining 

Documents Required

Updated and Printed Resume

2 Passport Sized Colored Photographs

Govt. Photo ID

Certificate of Registration

 

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Sr. Clinical Process Associate / Clinical Process Specialist-Quintiles 3 - 8 yrs Bengaluru/Bangalore

 
3,00,000 - 6,50,000 P.A 

Dear Candidate,

Opening in Quintiles for Records Management Professionals.


Exp: 3 years - 6 years


Criteria: Candidates having experience in Clinical Records Management, CRC, Clinical Research Co- ordinators,Clinical Data Mining, Clinical Data Documentation, Clinical Data Validation can apply for this role.


Designation: Sr. Clinical Process Associate / Clinical Process Specialist

Job - Description

Purpose

Apply clinical research expertise to provide project related assistance across complex and multiple project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.


RESPONSIBILITIES

Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines Establish and maintain effective project/ site communications
Create and maintain relevant project documents// trackers Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information Review, evaluate and recommend modifications to designated processes Oversee and participate in document management (creation, review, maintenance, storage, as applicable)
Participate in (study) team meetings and implement action items
Collaborate with the project lead/team members in creation/review of study documents
Act as point of contact for assigned deliverables for specific customers or projects
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues to relevant stakeholders and/or line manager.


If interested please forward your CV to thenmozhi.r@quintiles.com

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Clinical Research Coordinator-Excel Life Sciences Pvt. Ltd.

Job Description

 

We are hiring ClinicalResearch Coordinator for Delhi, Mumbai and Hyderabad.

Eligibility criteria ,

- Life science graduate
- Minimum 2 year of experience as a CRC

Job Description:

o Conduct site/trial feasibility to identify & select the right site and investigator for the study
o Ensure timely compilation of all essential documents & assist in regulatory package preparation, timely submission, follow up with site EC to resolve any queries, and obtain approvals
o Ensuring site setup according to protocol, review patient data base & pre-screening, identify physician network
o Coordinate for Clinical Trial Supplies receipt, accountability & storage
o Prepare site team for study initiation visit and coordinate with monitor for the visit
o Assist in the process of administering the informed consent to the potential Subjects and discussing in detail the patient information sheet
o Ensure that site documentation remains current, accurate and complete
o Coordinate for lab samples collection and logistics; review of lab reports and update PI
o Review & implement appropriate recruitment/referral activities for active enrolment at sites
o Ensure CRF Completion and query resolution on specified timelines
o Coordinate in conduct of Monitoring visits and Audits (Internal or External)
o Ensure that monitoring/audit related findings are resolved within the timelines
o Ensure patient follow up visit and vist compliance; manage patient related reimbursement; site related payment
o Drug receipt, accountability, storage, dispensing and related documentation
o Ensure adherence to protocol guideline, regulations, ethical guidelines
o Coordinate and ensure timely reporting to all stakeholders
o Maintain study log(s) & study manuals
o Assit monitor with the site closeout activities
o Manage final reconciliation of Clinical Trial Supplies and archival of study documents at sites

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HCL Urgent Requirement for Healthcare Counselor(bengali/tamil/punjabi) HCL Technologies Limited

 

  

 

Job Description

Dear Candidate,
We are pleased to inform you about the opening in Noida with the No. 1 Employer in India, HCL Technologies - Business Services for the profile of Health Care Counselor (Bengali/Tamil/Punjabi).
You can come for the Direct Walk-in on 26th & 27th Oct '2015 and collect On-Spot Offer Letter based upon the selection.
Process: Health Care
Designation : Counselor
Benefits of Joining HCL BPO:
*Pickup/drop facility
*Opportunity to fast track career growth
*International Standard Facilities
*Recreation, Cafeteria, ATM and Concierge facilities
*Regular Get together and other cultural programs
*Shuttle Facility available from Noida City Metro Station
Job Description :


Shift Window: 8 am - 8 pm
Salary : Best in the industry
Scope of the Role:
* Scheduling the appointments.
* Providing the Scheduled Appointments Details.
* Handling of customer/Patient Queries.

Key Roles and Responsibilities:
* Scheduling the appointments.
* Providing the Scheduled Appointments Details.
* Handling of customer/Patient Queries.

Domain, knowledge, skills and ability:
* Biology, Medical Terminologies.
* Knowledge of Pathology Test & Medical Specialties.
* Adequate working Knowledge of MS Office.

Verbal & Written communication / Language skills :
* Excellent Communication Skills Required.
*Fluency in Bengali/Tamil/Punjabi.
#Freshers and Experienced Both Can Apply
#Cabs Available
#No night shifts
Eligibility :
Good communication Skills
Education : B. Sc / M.Sc / B.Pharm / M.Pharm / Nursing.
Venue:
HCL Technologies Limited, N5 Building,
A-22, Sector - 60, Noida", UP - 201307
Walk in timings: 11.00 am to 6.00 pm
HR Contact: Priyanka Bisht

Also write Priyanka Bisht  on top of your resume.
*All candidates should carry resume & 1 passport size photograph

Sr. Executive / Officer-drug Regulatory Affairs- Verve Health Care Ltd

Job Description

 

Preparation and compilation of dossier(s) of Finished Product in CTD and ACTD format for ROW countries.
To prepare registration dossiers for various other countries as per country specific regulatory requirements.
To prepare & submit complete & accurate registration / re-registration documents & samples well within time & to reply to queries as may be raised by registration authorities.
To co-ordinate for samples to be submitted for registration.
Documentation, Review like MFR,PVR,AMV,STPs etc..
Coordinating with different departments regarding regulatory and quality compliance practices and for documentation.
Coordinating with relevant institutions regarding conduct of Bioequivalence studies, providing them with details of the innovator product and other specific requirements of the respective countries.
Providing guidelines for developing Packaging and Labels as per Global Labeling.
Search and retrieve the different registration guidelines and to keep the same as a data bank for ready reference (Database Management)

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Publication Support Specailist Cactus Communications

Job Description

 

What is publication support?

Under publication support, we offer a full range of services to meet authors publication needs. These services include helping authors select the most appropriate journals in which to publish their papers, preparing their manuscripts for submission, and helping them complete the journal submission process.

Would you like to help authors publish their research? And in the process learn from authors of different nationalities and widely diverse subject areas? If yes, then the CACTUS Publication Support team is the place for you! Working with us as a Reviewer will enable you to leverage your scientific knowledge in a corporate setup and engage in what you know best and are passionate about effective scientific communication.

Job Description

• Quality assurance of assignments turned in by freelance experts and providing them with constructive feedback
• Preparing and editing images and tables according to journal specifications
• Understanding client requirements and applying them to the different components of the publication support process (formatting manuscripts, checking submission requirements)
• Supporting the publication support managers in project management
• Driving or contributing to team initiatives, e.g., creation and management of resources

Location: Andheri (West), Mumbai

You fit the bill if you have:

• A Masters degree in any field of biological, physical or social sciences; candidates with a strong research orientation are preferred
• Strong command over the English language
• Strong client focus and work ethic (adherence to client requirements essential!)
• Good time management skills; strong deadline focus
• Ability to multitask across projects
• Willingness to take on the challenge of working in different subject areas

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Senior - Clinical Research Associate (vaccine)-Mumbai, Gurgaon

Job Description

Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Conducts site visits to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international quality assurance audits. Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members.

Responsibilities:

• Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification). Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalate observed deficiencies and issues to clinical management expeditiously, present solutions and follow all issues through to resolution. Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM). Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participate in investigator meetings as necessary. Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensure trial close out and retrieval of trial materials
• Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
• Contribute to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assist in project specific training for the clinical team where necessary. Identify areas for potential process improvements & share potential solutions for improvements.
• Perform additional tasks as assigned by CTM or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.
• Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Respond to company, client and federal regulatory requirements/audits.
• Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner

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TCS is Hiring B. Sc Fresher for Clinical Research- Back Office Process Tata Consultancy Services Ltd.

Job Description

 

Process: Life Science - Back Office . (Only Night shift)
Experience: 0 to 3 Month experience only. (2015 pass out)
Job Location: Mumbai
Skills: Good Communication skills (Written & Verbal)


Eligibility:
. Courses considered: BSC Fresher ONLY (Chemistry / Biology/ Botany/ zoology ) 2015 passout
. Candidates who have more than 3 month experience DO NOT apply
. B.E/ B.Tech / MCA / MSc / MBA/ BMM/ BMS/ MSc/ MPharm. Strictly need NOT apply.
. Only full time courses considered.
.Should NOT have 2 years break in education.
.Should NOT have any backlogs.
.Should NOT have attended any TCS interview in last 6 months.
.Should be willing to work in NIGHT SHIFTS.(Only Night shift)


Interested Candidates are requested to forward your resume to satish.sugunan@tcs.com or what app on 7276546193.

A Critical Evaluation of Clinical Research Study Designs

Prior to starting any clinical research, an investigator must determine the appropriate study design to answer the question at hand. Selecting the correct study type also depends on ethical considerations, disease of interest, and the resources available. A well-designed study will clearly identify an exposure and an outcome in an objective, quantifiable manner to answer a defined hypothesis. After thorough data analysis and discussion of the results, the study will ideally prompt further research on the subject. Understanding the various indications for different study designs is important not only for devising one’s own study but also for critically reviewing the literature. This article outlines frequently encountered study designs in clinical research and their respective strengths and drawbacks.

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Cancer 2015: A longitudinal whole-of-system study of genomic cancer medicine

Genomic cancer medicine promises revolutionary change in oncology. The impacts of ‘personalized medicine’, based upon a molecular classification of cancer and linked to targeted therapies, will extend from individual patient outcomes to the health economy at large. To address the ‘whole-of-system’ impact of genomic cancer medicine, we have established a prospective cohort of patients with newly diagnosed cancer in the state of Victoria, Australia, about whom we have collected a broad range of clinical, demographic, molecular, and patient-reported data, as well as data on health resource utilization. Our goal is to create a model for investigating public investment in genomic medicine that maximizes the cost:benefit ratio for the Australian community at large.

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Openings @ Quintiles,for Medical Data Reviewer-only Medical Graduates

Job Description

Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy and medical consistency
Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified. Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE
Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
Ensure proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial
Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
Review additional information, as necessary, to determine overall readiness of the patient information for next level review
Review all supplied Line Listings, patient profiles to determine data accuracy across patients within a specified group of data points
Review status information and data flow reports and take appropriate actions
Serve as POC/ Back-up POC
Interact with other Medical review staff to verify/clarify information and/or triage new data issues or prior identified action items
Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

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B. Sc Fresher for Clinical Research- Back Office Process

Job Description

Process: Life Science - Back Office . (Only Night shift)
Experience: 0 to 3 Month experience only. (2015 pass out)
Job Location: Mumbai
Skills: Good Communication skills (Written & Verbal)


Eligibility:
Courses considered: BSC Fresher ONLY (Chemistry / Biology/ Botany/ zoology ) 2015 passout

Interested Candidates are requested to forward your resume to satish.sugunan@tcs.com or what app on 7276546193.

Clinical Research Associate's ( Blore / Chennai / Hyd / Delhi / Ahm )-Quintiles

POSITION SUMMARY:
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements

RESPONSIBILITIES

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist CRS) and/or line manager.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Act as a mentor for clinical staff including conducting co-monitoring and training visits.
May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Strong knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Strong therapeutic and protocol knowledge as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Strong written and verbal communication skills including good command of English language
Strong organizational and problem-solving skills
Effective time management skills
Ability to manage competing priorities
Good mentoring and training skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a health care or other scientific discipline or educational equivalent and 2 5 years of on-site monitoring experience; or equivalent combination of education, training and experience.

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Pharmacovigilance Data Manager-Novartis Healthcare Pvt. Ltd.

 

Job Description

 

Understand and translate data retrieval need into query request, create query criteria, retrieve data from the safety database and provide the results to IMS staff or external line functions . 2. Perform QC check on data retrieved; Identify errors/inconsistencies in outputs and resolve them or initiate their resolution. 3. Generate regulatory reports, standard reports, tabulations, graphs and retrievals in preparation for regulatory submission 4. Coach, train and mentor new Safety Data Management personnel as appropriate. 5. Lead, coordinate or support data management initiatives as and when needed. 6. Testing and validation activities to support operational change requests and IMS IT projects. 7. Development, testing and validation of new reports and/or cognos cubes for the IMS STAR data query and analysis tool. 8. Electronic unblinding of relevant SAEs from clinical trials in the safety database, as appropriate.
Manage daily operation and complete the task as per require TAT. 

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Senior Pharmacovigilance Data Manager Novartis Healthcare Pvt. Ltd.-Hyderabad / Secunderabad

 

Job Description

Involved in providing a high level of expertise to retrieve data and prepare complex outputs from the Pharmacovigilance database to support the analysis of drug Pharmacovigilance related tasks. - Use their experience of pharmacovigilance data management to mentor, train and deliver a high level of expertise during approval of activities to other data managers. - Identify process improvements and lead data management related activities. - Contribute in ensuring harmonization in the retrieval of data and in the preparation of outputs from the Pharmacovigilance database to support the analysis of drug Pharmacovigilance related tasks.
Support other Pharmacovigilance Data Managers and DS&E customers or other external line units by providing a high level of expertise concerning the definition and/or implementation of Complex retrievals. Perform QC check on complex data retrieved; Identify errors/inconsistencies in outputs and resolves them or initiates their resolution. Provide input and review database design, validation checks and necessary reports to ensure high quality and consistent data during retrievals. Coach, train and mentor new Pharmacovigilance Data Management personnel as appropriate. Act as the business lead for assigned DS&E data management activities. Proactively identifies opportunities for improvement and harmonization of Pharmacovigilance Data Management and DS&E business processes and proposes and implements new solutions. Involved in testing and validating activities to support operational change requests and DS&E IT projects. Assist Department Head in defining Pharmacovigilance data management strategy and guidelines in order to establish common rules for assessing adverse event reports. Assist and deputize for the Pharmacovigilance Data Management Head as appropriate. Assist Pharmacovigilance Data Management Head in writing procedural documents as appropriate. 

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Operations Manager for Pharmacovigiliance-Wipro BPS (A division of Wipro Limited)

 

ROLES & RESPONSIBILTY :

•  Manage and grow Pharmacovigiliance operations
• People management & people development leading to retention
• Ownership of customer reviews
• Drive CSAT & NPS improvement
• Meet revenue and profitability goals
• Conduct regular reviews.

 EDUCATION & EXPERIENCE:

• B.Pharma / M.Pharma with valid Pharmacy registration
• Min 2-3 years of experience in independently managing US Pharma delivery with a min total experience of 7 years
• Must have been in a customer facing role for >4 years
• Must have lead business reviews in previous role
• Flexibility to work in evening / rotational shifts
• While the base location would be Delhi/NCR, but the candidate should be willing to relocate to another India or International locations if required
• Good analytics ability, ability to multi-task
• Willingness to work and ability to perform in a highly dynamic and fast paced environment
• Must have in-depth understanding of Pharmacovigilance contracts
• Manpower / Project planning exposure
• Must have been responsible for a span of minimum 50-70 FTEs 
• Experience of participation in new bids / RFPs is highly desirable
• Flexible with customer shifts and ability to adapt to internal/customer requirements

CANDIDATE SHOULD BE COMFORTABLE  WORKING IN ROTATIONAL (24*7) SHIFTS.

JOB LOCATION:

New Delhi ( Sarita Vihar)

If Interested Please share your resume at Kanika.sharma8@wipro.com

Senior Drug Safety Specialist-Dr. Reddy's Laboratories Ltd.

 Job Description:

Quality check and review of individual case safety reports (ICSRs) based on accepted industry and regulatory guidelines.
Write various safety reports for global regulatory submissions including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events.
Review of literature search output or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
Overview compliance of ICSR with governing regulatory requirements

Skills
Masters degree in Pharmacy or Life sciences with at least 3-4 years of experience in the pharmacovigilance.
Prior experience of ICSR processing in pharmacovigilance/drug safety field.
Experience of aggregate report writing specially PBRER.
Familiarity with the global reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities.
Strong written and verbal language skills
Ability to analyze and synthesize medical information.
Eye for quality, detail orientation for various pharmacovigilance processes.

Recruiter Name:Venkat Vishwanath

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Senior Drug Safety Associate - Aggregate Reporting-Synowledge PV Services India Pvt Ltd

JOB TITLE: Senior Drug Safety Associate - Aggregate Reporting

LOCATION: Mysore, India.

YEARS OF EXPERIENCE: Minimum 2 years of experience in AR.

EDUCATION: Bachelors degree in Pharma/equivalent in a related discipline.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

As Lead Author: 

 
Lead/Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements.
Support roles involved in creation of Aggregate Safety Reports (ASRs) (i.e. PSURs, PADER, DSURs, PBRERs, Addendum to Clinical Overviews, Addendum to PSURs, Summary Bridging Reports and RMP Updates).
Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template.
Compile the safety data into the relevant sections of periodic reports such as PBRER, PADER, and DSUR according to the client.
Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal deduction.
Create all documents in accordance to all applicable SOPs, and convention of the client.
Plan, organize, and manage daily work to meet service level timelines and deliverables.
Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.
Provide word and PDF versions of the final signed documents to the client.
Participate in internal and external audits and inspections by clients and health authorities.

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Pharmacist (fresher most Welcome)-3,50,000 - 8,00,000 P.A.

Bengaluru/Bangalore , Mumbai , Pune , Hyderabad / Secunderabad , Chennai , Delhi/NCR(National Capital Region)

 

We have urgently required the Fresher candidates and Fresher Candidate can apply directly also to send their resume and one passport size photograph to our company email address - apply@khaitangroup.com 

 

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Wish you and your family members a happy and prosperous festive season. Hope it will bring more happiness, peace and success into our life.

Idea to Market: The Drug Approval Process-It's a journey

Drug development can generally be divided into phases. The first is the preclinical phase, which usually takes 3 to 4 years to complete. If successful, this phase is followed by an application to the FDA as an investigational new drug (IND). After an IND is approved, the next steps are clinical phases 1, 2, and 3, which require approximately 1, 2, and 3 years, respectively, for completion ( Table ). Importantly, throughout this process the FDA and investigators leading the trials communicate with each other so that such issues as safety are monitored. The manufacturer then files a new drug application (NDA) with the FDA for approval. This application can either be approved or rejected, or the FDA might request further study before making a decision. Following acceptance, the FDA can also request that the manufacturer conduct additional postmarketing studies. Overall, this entire process, on average, takes between 8 to 12 years. Figure 1 summarizes the drug approval process.

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Wish everyone a very very happy navratri

Biomarkers in Preclinical Drug Development: Current and Future States.

Biomarkers are commonly used in clinical trials to identify organ injury before it becomes clinically evident. While they add value in early discovery work and in human trials to identify major safety issues, their potential has not yet been fully reached in preclinical development in animals. This paper explores the current state of biomarker use in preclinical development and examines possible steps for future use. Current State One Piece of the Puzzle It’s important to note that biomarkers must be used in conjunction with other traditional clinical and pathology endpoints. When used with other data, they can be used to identify premonitory signals signifi cantly earlier than when utilizing traditional tests alone. But there may be instances in which biomarker results can confound data interpretation. Due to the sensitivity of many biomarker assays, a biomarker may show evidence of a certain toxicity in the absence of correlative fi ndings among other, more traditional study endpoints. In these cases the biomarker may be identifying a submicroscopic eff ect that cannot be detected through traditional means. Since biomarker use in preclinical studies is not a regulatory requirement, some scientists are hesitant to use biomarkers because they are concerned about explaining these results. Therefore, it’s important to discuss the benefi ts and potential drawbacks of using biomarkers during the planning stages of a toxicity study. The more that is understood about the mechanisms involved in the biomarker’s signaling pathways, the easier it is to explain its results. A pathologist should be consulted pre-study to determine how and when to use the biomarker most eff ectively. Understanding the timing of the pathologic processes involved is critical to yielding meaningful results. For example, it may be necessary to draw blood samples within hours or days of dosing to capture the positive signal instead of waiting until the end of the study when the signals may no longer persist. Quality over Quantity Ideal biomarkers must function both analytically and from a pathological perspective, so while analytical teams are continually discovering new biomarker targets, there must be collaboration with pathologists to ensure these markers will be useful in practice. What are the characteristics of a good biomarker? A good biomarker must be present in body tissue and/or fl uids, easy to detect in aff ordable assays, and “its appearance must be associated as specifi cally as possible with damage of a particular tissue, preferably in a quantifi able manner.” 1 What are the characteristics of a validated biomarker? While it’s fairly straightforward what makes a good biomarker, characteristics of a validated biomarker are still up for debate. The Predictive Safety Test Consortium (PSTC) was created by scientists in academia and industry with the goal of qualifying new biomarkers “for the detection and monitoring of drug-induced toxicity in preclinical and clinical studies.”2 • In 2008, Kidney injury molecule-1 (Kim-1, in rodents), along with six other markers, was approved by the FDA as an acceptable biomarker “for the detection of acute drug-induced nephrotoxicity in rats and can be included along with traditional clinical chemistry markers and histopathology in toxicology studies.”3,4 • In 2010, the FDA published guidance on the Qualifi cation Process for Drug Development Tools, which stated that “qualifi cation is a conclusion that within the stated COU [context of use], the [drug development tool] can be relied on to have a specifi c interpretation and application in drug development and regulatory review.”5 Qualifi cation through the FDA is voluntary, and the COU can be expanded incrementally over time with appropriate data. • In the last several years, troponins have been established as a reliable biomarker for cardiovascular injury.6 In 2012, they were concluded by the FDA to be qualifi ed biomarkers for use in rats and dogs, in certain preclinical circumstances.7 While organizations like the PSTC continue to make strides in developing tests for biomarkers for preclinical use, minimum threshold criteria for an acceptable validation of a preclinical biomarker have not been published (the way they have been for clinical biomarkers), so there is still a spectrum of what is considered a validated or qualifi ed biomarker. Many preclinical labs involved in biomarker work adopt similar validation practices, which usually include inter/intra-assay precision and accuracy, dynamic range, upper and lower limits of quantitation, dilution linearity, spike-and-recovery, parallelism, and stability, but agencies have yet to create standardized guidance for all labs to follow. Lack of Oversight The manufacture of biomarker kits used in preclinical studies is not currently regulated, so one cannot assume that every kit on the market is functional. Individual labs must do the due diligence for each kit to ensure analytical performance, as well as performance from a biological perspective (e.g., using serum samples from animals with a known pathology to verify kit functionality). This can be a large investment upfront, but establishing a reliable kit supplier and using preclinical biomarkers to detect injury early can save considerable time and money once a drug program is underway. Individual methods must also be taken into account: two diff erent kits may use completely diff erent methods for the same biomarker, so it’s advisable to maintain consistency of methods and manufacturer throughout a program to ensure an apples-to-apples comparison between results from diff erent studies. This may not always be possible between species as species-specifi c reagents are not available for all biomarkers. Future State In order for preclinical studies to truly reap the full range of benefi ts that biomarkers can off er, we hope to see a few changes over the next several years. Standardization is Crucial The industry needs more guidance from regulatory agencies on the minimum requirements for validation, so that each lab can universally adhere to one set of standards. This will help to remove the subjective nature of what a “good” biomarker is and will result in a consistent set of standards used across the industry. The Biomarker Qualifi cation Review Team (BQRT), comprised of reviewers from CDER and other FDA branches, also acknowledges that “a standardized format for submitting preclinical and clinical data is needed for an effi cient and accurate review.”8 Establishing a Trustworthy Set Biomarker development needs collaboration between pathologists and analytical groups. Both types of specialists are critical to developing biomarkers that are useful in preclinical studies. Once more standards for validation and data submission are established by regulatory agencies, teams can work together to streamline the discovery of preclinical biomarkers and submission for review. As more biomarker data is collected and made accessible to the community, more time can be saved in choosing the appropriate marker for a study, and in understanding sensitivity and interpreting results. Page 2 of 3 Adam A. (2014) Biomarkers in Preclinical Drug Development.
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Record Management Clinical Research-Kelly Services India Pvt. Ltd.-Bengaluru/Bangalore

2,00,000 - 4,00,000 P.A

Job Description

s

Greetings from kelly services!


We have an immediate openings for Clinical research Record management. Interested candidates can walkin on 19th October,2015.


Experience : 0.6months to 4 years
Venue : Sriram Samanthu Chambers, # 3287, 12th Main Indiranagar, Bangalore| India 560038
Near HDFC bank, Salary:INR 2,00,000 - 4,00,000 P.A
Recruiter Name:Sarada

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How Companies Can Make the Most of Their Early Drug Development Stage

Background

Companies large and small face enormous risks during the crucial early drug development stages. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), major pharmaceutical and biotechnology companies spent $10.5 billion or 22% of total annual R&D costs on non-clinical research in 2011 — more than the total amount spent on Phase I and II activity combined.i While the failure rate tends to diff er for small molecules and biologics, the majority of development eff orts fail, with the rate generally falling between 60 and 90%. With the new technologies and services available to Sponsors, the traditional path to drug development is no longer the best solution. With the right planning and tools, the studies conducted in the preclinical and early clinical stages can lay a foundation that will reduce risk and maximize the investment in future stages.

Focus on De-Risking a Molecule: The Rise of Translational Medicine

Facing rising R&D costs and increasing pressure to appease investors, companies must discover early on if a potential drug is too risky to pursue. There are many risks in early drug development, which can be grouped into three main categories: safety, efficacy, and time to market. To mitigate the risk in the latter category, companies must move with insightful speed — performing the right studies to obtain the best data — to stay ahead of competitors. The knowledge that a potential drug carries too much risk can save millions, and it also builds trust with stakeholders who see that there are sound decision-making processes in place, and that resources are being carefully allocated. 

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Principles of nanoparticle design for overcoming biological barriers to drug delivery

Biological barriers to drug transport prevent successful accumulation of nanotherapeutics specifically at diseased sites, limiting efficacious responses in disease processes ranging from cancer to inflammation. Although substantial research efforts have aimed to incorporate multiple functionalities and moieties within the overall nanoparticle design, many of these strategies fail to adequately address these barriers. Obstacles, such as nonspecific distribution and inadequate accumulation of therapeutics, remain formidable challenges to drug developers. A reimagining of conventional nanoparticles is needed to successfully negotiate these impediments to drug delivery. Site-specific delivery of therapeutics will remain a distant reality unless nanocarrier design takes into account the majority, if not all, of the biological barriers that a particle encounters upon intravenous administration. By successively addressing each of these barriers, innovative design features can be rationally incorporated that will create a new generation of nanotherapeutics, realizing a paradigmatic shift in nanoparticle-based drug delivery.
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Openings for Freshers- Pharmacovigilance-Bengaluru/Bangalore-2,00,000 P.A

Job Description

 

Looking for freshers who has completed their graduation B.Pharma/M.Pharma/ BDS/ M.Sc/B.Tech.

RESPONSIBILITIES
Provide intake and tracking of initial safety and clinical event validation and adjudication (CEVA) data. Transfer incoming
safety/CEVA data to project team. Identify any problems with incoming faxes and bring them to the attention of the senior
team member.
Distribute safety data to marketing authorization holders, customers, regulators and investigators.
Specific project responsibilities include set-up and/or maintenance of safety/CEVA files for reported events; archiving of
files when closed; coordination of transfer of archived material to company/customer archive storage facilities;
preparation and assistance in setting-up and updating project files; maintenance of personal safety files for mail merges
and regulatory documents; where required, data entry of events into tracking database and assistance of transfer of
events to customers.
Provide administrative support for the department by coordinating team/department/customer meetings, coordinating
stationery orders, dispatching data via courier services, reserving meeting rooms and IT equipment; and providing
secretarial support as required.
Generate and distribute alert letters.
Identify and record quality problems and bring them to the attention of a senior team member.
Provide training/mentoring new/less experienced staff.
Assist project lead and CEVA management with specific aspects of CEVA processes.
Set up and maintain Serious Adverse Event (SAE) files for reported events; organize and send files for archive when
events are closed.
Coordinate, schedule and submit reports to regulatory authorities in accordance with deadlines.
Coordinate distribution of safety letters to study investigators and Clinical Research Associates.
Assist in processing incoming and outgoing Adverse Event (AE) reports by collecting and tracking incoming AE reports
sent via fax, email, eCRF, etc; determining initial/update status of incoming events; tracking timelines for completion of
AE processing; performing data entry into safety database; routing report information to appropriate PhV project
personnel in the workflow for continued processing; performing quality control activities as directed by project lead or
manager; generating established safety data reports; submitting AE reports to client and other project team members
identified by project lead; obtaining confirmation of report receipt and track submission; and assuming workflow
responsibilities for local and global projects.
Perform records management tasks such as creating and tracking case folders for AE reports; filing, retrieving and
delivering case folders; assisting in maintenance of document control room and relevant applications/systems as directed
by manager; archiving case folders and project files; assisting in creation of PhV records management processes and
procedures; providing key input to management on acquisition and/or upgrade of records management
application/systems; and serving as liaison between Pharmacovigilance department and records management
department.
Assist with system support tasks such as utilizing design specifications, AE form, and protocol, creating projectspecific
entry specifications and annotated AE forms for safety database with direction from project lead and/or manager;
creating project tracking spreadsheets and associated tracking entry specifications; assisting in database validation
through performance of user testing; performing ad hoc database searches for project team leads; assisting project lead
in assessing database setup needs; and assisting with assuring systems issues are reported and resolved.
Perform additional project-related and administrative tasks such as handling investigator mailings including creation of
labels using investigator list, copying of documents, envelope stuffing, and tracking and filing of submitted materials;
creating and maintain project files; working with project lead to develop project instructions; performing reconciliation
between the safety and clinical databases; distributing AE listings to client and/or project team members; performing
project start-up tasks; providing project metrics to management; and assisting with data entry, workflow and deadline
quality measurements.
Participate in continuous improvement of all departmental processes and procedures.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Basic knowledge of ICH and GCP
Basic knowledge of medical terminology if processing
Good understanding of Core Operating Procedures (COPs)
Word processing and data entry skills
Strong organizational skills and time management skills
Flexibility and excellent verbal and written communication skills
Ability to deal successfully with many internal clients competing for attention, services and resources
Good attention to detail and accuracy
Ability to establish and maintain effective working relationships with co-workers, managers and colleagues.
Highly motivated and organised with a flexible attitude
Ability to follow instructions/guidelines, utilize initiative and work independently
Ability to establish and maintain effective working relationships with coworkers, managers and clients


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Quintiles Hiring Clinical Research Professionals - 17-oct-15 Hyderabad

Job Description

Walk in Interview - Quintiles on 17-Oct-15 for ClinicalResearch Professionals in Hyderabad. Key Skills:- CRC, CPC, CRA, Research, Clinical Research, Scientists, Medical Writing, CDM, PV.


Experience 3-8 years.
Hyderabad Interview Venue Details:-

Aditya Park- A Sarovar Portico Hotel
Aditya Trade centre | Ameerpet | Hyderabad -38
Registration Time:- 8am


Position 1: Clinical Process Specialist/Analyst

PURPOSE
Apply clinical research expertise to provide project related assistance across complex and multiple  project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.


RESPONSIBILITIES

Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines                                                                                                                                                                                   
Establish and maintain effective project/ site communications                                                                           
Create and maintain relevant project documents// trackers                                                                                                                                                                                                                                    
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information                                                                                                                                  
Review, evaluate and recommend modifications to designated processes
Oversee and participate in document management (creation, review, maintenance, storage, as applicable)
Participate in (study) team meetings and implement action items
Collaborate with the project lead/team members in creation/review of study documents
Act as point of contact for assigned deliverables for specific customers or projects
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues to relevant stakeholders and/or line manager


Position 2: Sr Clinical Process Specialist

PURPOSE

Apply clinical research expertise to provide project related assistance across complex and multiple project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. Mentor/ coach Clinical Process Associate/Specialist colleagues.


RESPONSIBILITIES

Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines                                                                                                                                                                                   
Establish and maintain effective project/ site communications                                                                           
Create and maintain relevant project documents/ trackers                                                                                                                                                                                                                                     
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information                                                                                                                                  
Review, evaluate and recommend modifications to designated processes
Oversee and participate in document management (creation, review, maintenance, storage, as applicable)
Participate in (study) team meetings and implement action items
Collaborate with the project lead/team members in creation/review of study documents including Quality manuals
Act as point of contact for assigned deliverables for specific customers or projects
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues to relevant stakeholders and/or line manager.
Coach junior clinical process associate/specialists


Interested Candidates can Walk In to the above mentioned address or forward the CV to Sindoora.kn@quintiles.com.