Walkin Drive on 12th Dec 2015 for Clinical Data Management in Mumbai

Dear Candidates,

Greetings from Quintiles!!!

We are having a Walkin drive  for CDM and have multiple position open in Mumbai on 12th DEC 2015 venue would be shared shortly. Please share your CV to bincy.mathew@quintiles.com

Job location:Mumbai

Job Title : Clinical Data Coordinator/Sr. Clinical Data Coordinator/Data Team Lead

RESPONSIBILITIES
Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or a
leadership role in a specific area or process on a large study with guidance.
Serve in the role of back-up to a Data Operations Coordinator or Data Team Lead.
Conduct data review.
Write and resolve data clarifications.
Lead database audit team.
Develop and test databases and edit specifications.
Understand and comply with core operating procedures and working instructions.
Meet objectives as assigned.
Develop and maintain good communications and working relationships with CDM team.
All responsibilities are essential job functions unless noted as nonessential (N).
Exp::RAVE,Oracle,OCR-DC etc.
Note: Kindly ignore if irrelevant.

Recruiter Name:HR
Address:Quintiles,Etamin Block, Wing B, I floorPrestige Tech Park II, Outer Ring RoadSarjapur, Bangalore - 560103BANGALORE,Karnataka,India 560103

Drug Safety Division (regulatory Affairs)

• Review of task and allocation of assignments to team members
• Analyse performance of team members periodically to ensure compliance with organizational SOP, regulatory guidelines and quality metrics
• Identify training needs for the new employee/ team members to ensure quality and accuracy in activities handled
• Co-ordinate with legal department for signing CDA, MSA and SOW with the vendor
• Monitor performance of vendor as per SOW, KPI s and SOPs
• Attend weekly calls with vendors and ensure timely escalation of outstanding issues
• Perform periodic/ as- hoc audit of the vendors
• Assist in the development of departmental SOP's and work instructions
• Review of PADERs, PBRERs and PSURs
• Involvement in signal detection activities and in DSRC meetings
• Configure product, study, formulation in Argus database as per requirement
• Perform periodic and frequent review of Argus database as per requirement
• Perform periodic and frequent review of Argus database to determine status of reportable cases by generating of line listing as per SOP
• Assign PADERs to the team members at the start of the month
• Through knowledge of Pharmacovogilance activities

APPLY ONLINE

Drug Safety Associate

We are expanding! Hiring Drug Safety Associates to be based @ our GDC in Mysore.

Position: Drug Safety Associate

Work Location : Mysore

Experience : 0 to 1 year

Shifts : Flexible to work in shifts (including night shifts)

Educational Qualification :

Any HCP ( BPharma / MPharma / Pharm D / BDS / MDS / BAMS / BHMS / BPT / MPT / BSc Nursing)

Non HCP Post Graduates in Microbiology, Bioinformatics, Clinical Research, Biophysics, Molecular Biology, Medicinal Chemistry, Nuclear Sciences, Biochemistry, Biotechnology

Role & Responsibilities

Case Processing
Medical Coding
Narrative Writing

Walk In Date : Saturday, 5th December 2015

Walk In Time : 10:00 AM

Venue:
Synowledge Bangalore
#120/A, Elephant rock road,
Jayanagar 3rd Block,
Bangalore -560 011. India

APPLY ONLINE

NH- Pharmacovigilance

PURPOSE OF THE JOB

The position manages a group of highly experienced DSU, Case Processing and Medical Review team in the PV project. The profile is the primary interface with the client team.

MAIN ACCOUNTABILITIES

Accountable for performance, consistency, and quality of the deliverables.

Ensure team members are trained and mentored appropriately.

Ensure the completeness and validity of cases submitted to the client.

Ensure product delivery to client timeline and quality expectations.

Resolve data issues with the Client Team.

Balance workload within a team of DSU, CP & MR programmers and ensure timelines are met.

Implement measures to ensure corrective actions are taken.

Resolve any issues identified by the team.

Accountable for providing updates to the team any changes in the way in which work is performed. Ensure efficiency of operations.

Update the employee ware house

hosting the individual productivity and employee leave details within the defined time frames.

Provide feedback to QC roles for quality and efficiency improvement and ensure necessary corrective measures are taken.

Production ready assessment support new employees in their Production work.

Organize mentoring for new employees as and when required.

Recruit and hire the right skills

Identify opportunities for continual improvement.

Implement best practices for quality deliverable to client.

People management and mentoring team members to ramp up and deliver as per client requirements.

Ensuring customer satisfaction on project deliverables.

Ability to manage a team size of over 80

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External Consultant / Trainee Analyst - PV IMS Health India Pvt Ltd

• Good medical and pharmacovigilance (PV) knowledge to guide and train the team on related medical content, besides being able to detect adverse events in qualitative data using medical knowledge
• Basic knowledge and understanding of the global pharma industry
• Awareness of the various regulatory guidelines involved in PV
• Quick decision-making skills (e.g., classification into doubtful adverse event vs. AE vs. serious AE, or no AE)
• Excellent (verbal/written) communication and interpersonal skills
• Great eye for detail for flawless execution and QC review
• Demonstrated project management skills and time management skills to deliver projects on time or ahead of schedule
• MS Office - PowerPoint, Excel, and Word
• Drive for excellence and passion for quality, with the ability to adapt to international culture (applicable in analyzing slang and colloquial terminology)

Strongly desirable competencies:

• Ability and passion for continuous learning
• Inclination and interest to learn more about adverse event reporting / Pharmacovigilance
• Excellent problem solving skills

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Adverse Drug Reactions

Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have. ADRs can be considered a form of toxicity; however, toxicity is most commonly applied to effects of overingestion  or to elevated blood levels or enhanced drug effects that occur during appropriate use (eg, when drug metabolism is temporarily inhibited by a disorder or another drug).Side effect is an imprecise term often used to refer to a drug’s unintended effects that occur within the therapeutic range. Because all drugs have the potential for ADRs, risk-benefit analysis (analyzing the likelihood of benefit vs risk of ADRs) is necessary whenever a drug is prescribed. Read More

Your Patient Has an Adverse Reaction to a Drug: How to Report to FDA's MedWatch

This article is the first in a series of activities in collaboration with the Food and Drug Administration (FDA) and Medscape Education on how to report safety issues to the FDA and how these reports are used to ensure safe use of drugs and medical products.

Healthcare professionals must remain knowledgeable and vigilant about the latest drug and device safety issues and other adverse events that may affect patient health outcomes. Physicians, physician assistants, advanced practice nurses, nurses, pharmacists, and other providers often are the first to identify and witness the negative effects of drug-drug interactions, drug use errors, malfunctions and flaws in medical devices, or other adverse events.

Documenting these types of problems is critical to the safety of patients and clinical practice. The healthcare professional must disseminate these findings to help inform the medical and public health communities and the general public of these potential serious adverse events or issues associated with a medication or medical product.

The US Food and Drug Administration (FDA) established MedWatch, the FDA Safety Information and Adverse Event Reporting Program, to assist healthcare providers and the general public in notifying the agency of adverse events or medical product errors.

To learn more about the MedWatch program and the types of safety information to report through the system,Medscape Education recently interviewed Anna M. Fine, PharmD, MS, director of the Health Professional Liaison Program, Office of Special Health Issues. Dr. Fine oversees the MedWatch educational outreach program. Read More

FDA Information on Vasostrict Storage

The FDA’s drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product. For instance, the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected strength, quality, and purity and identify appropriate storage conditions to maintain drug quality. Furthermore, FDA’s review of the applicant’s labeling ensures that health care professionals and patients have the information necessary to understand a drug product’s risks and its safe and effective use.

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Clinical Research Associate SaiSun hiring for Leading Pharma Company 1 - 6 yrs Mumbai , Ahmedabad

B Pharm / M Pharm with minimum 1-2 years of hardcore monitoring experience in Clinical Trials.

Therapeutic experience in Oncology, Neurology, Diabetology.

Good communication skills (written & verbal).

Positions : 5 ( 2 in Mumbai and 3 in Ahmedabad)
Package:- 3.5 LPA to 4.0 LPA
Immediate joining

APPLY ONLINE

Quintiles Freshers Walk-in Event on Sat ,28th Nov (clinical Research) Quintiles

Job Description

 

We are hiring freshers with life science background and knowledge on Clinical Research ,clinical trial & ICH-GCP guidelines and regulations. 


Excellent communication skills must.


Flexible to work in shifts (6:30AM-2PM & 2PM-10:30 PM)
Cabs are provided within 30kms of distance.


if interested please walkin directly , please carry Updated CV,copy of this mail ,PAN CARD.
Also share your CV & scan copy of PAN CARD to the following id: sudhamani.m@quintiles.com


PFB the JD for your reference:-


About Quintiles
Quintiles is the worlds largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions from pipeline through portfolio to population health . A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
PURPOSE
Engage in company training program to gain knowledge and skills required to provide administrative support to projects under direction of line manager and/ or Clinical Process Associate and/ or other designated team members.

RESPONSIBILITIES
Complete appropriate role-specific training to perform job duties
Under supervision, perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.)
Under supervision, assist in updating and maintaining systems within project timelines and per project plans

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Basic knowledge of applicable research and regulatory requirements, i.e., ICH GCP and relevant local laws,
regulations and guidelines
Exposure to MS Applications including but not limited to Microsoft Word, Excel and PowerPoint
Effective written and verbal communication skills including good command of English language
Effective time management skills
Results and detail-oriented approach to work delivery and output
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Strong listening and phone skills
Good data entry skills

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Graduate or educational equivalent up to 6mths of relevant experience; or equivalent combination of education, training and experience.


Venue: Quintiles

Ground Floor, Etamin Block- A wing
Prestige Technology Park
Sarjapur-Marathahalli Outer Ring Road
Bangalore - 560103


Registration time: 8:00 AM to 9:00 AM


Interested candidates could walkin at the above mentioned venue.


Regards,
Sudha

PPD Moves Trial Management and Monitoring to the Oracle Health Sciences Cloud

PPD, one of the top CROS worldwide, is reducing trial timelines, cost, and risk through simplified data exchange and monitoring with Oracle Siebel CTMS Cloud. PPD successfully migrated data from 124 studies to the Oracle Health Sciences Cloud in just six weeks, achieving rapid time to value.
With this highly available and secure monitoring cloud, PPD and trial sponsors gain actionable insight into studies to accelerate clinical development while reducing trial costs and risk. As PPD put it:
“Oracle Siebel Clinical Trial Management System Cloud Service dramatically simplifies how we manage study data and communicate with clients, especially in studies involving multiple CROs…saving us time, reducing the cost of studies and creating better results for our clients.”

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FDA approves first seasonal influenza vaccine containing an adjuvant

The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.
Fluad, which is manufactured using an egg-based process, is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil. Squalene, a naturally occurring substance found in humans, animals and plants, is highly purified for the vaccine manufacturing process. Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual.
According to the Centers for Disease Control and Prevention, in recent years, it is estimated that 80 to 90 percent of seasonal influenza-related deaths and 50 to 70 percent of seasonal influenza-related hospitalizations have occurred among people 65 years of age and older.

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Quintiles Walk-in Event on 28-nov-15 (clinical Research Professionals) Quintiles 1 - 6 yrs Bengaluru/Bangalore

Greetings from Quintiles!

We are having a walk in event for the below roles:

1. ClinicalResearch Professionals Candidates with 1 to 8 years of experience in clinicalresearch field. Preferably candidates with site monitoring experience. (Job # 1517352)

2. Project Management professionals candidates with 5+ years of experience in line management in clinical / healthcare

domain (Job # 1517361)

3. ClinicalResearch freshers looking for candidates with strong clinical background and communication skills who have good domain knowledge (Job # 1524797)

All roles require excellent communication skills and will involve working in shifts.

Interview Location:

Quintiles
Etamin Block, Wing A, Ground floor
Prestige Tech Park II, Outer Ring Road
Sarjapur, Bangalore - 560103


Clinical Roles:

PURPOSE

Apply clinicalresearch 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.


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Advanced knowledge of clinical trial conduct, and skill in applying applicable clinicalresearch regulatory requirements;

i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related systems and software utilized in clinical operations.

Strong written and verbal communication skills including good command of English language

Results and detail-oriented approach to work delivery and output

Project Control Professionals:

The Project Controls Professional (PCP) assists in the monitoring, controlling and communication of project performance. This position reports to the Clinical Project Manager, through a dotted line reporting relationship, and is responsible for directing and/or coordinating project planning & scheduling, estimating, cost control, change management and risk management.

Roles & Responsibilities:

General Attributes

1. Establishes and maintains a project monitoring, control and reporting system that supports on-going assessment of project performance and facilitates informed and timely adjustment of project execution to achieve project objectives

2. Develops and maintains the Project Execution Plan sections related to project tracking, trending, reporting and change control elements

Applies strong time management, planning, organizational, decision making and problem solving skills to resolve issues in an effective and timely matter

Interested Candidates Please forward your resume to sindoora.kn@quintiles.com or directly Walk-in to the Venue.

Regards,
Sindoora

Openings for Freshers- Pharmacovigilance Quintiles 0 - 0 yrs Bengaluru/Bangalore

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.

APPLY ONLINE

Open Walkin for Pharmacovigilance Experienced(2+ in pv) on 28th Nov Quintiles 2 - 7 yrs Bengaluru/Bangalore

Dear Candidate,

Open walk in for experienced(2+ years in PV) on 28th Nov 2015.

Event details:

Date- 28-Nov-2015
Registration Timings - 8 am to 9:30 am
Documents to carry Copy of this mail, Updated CV, Id proof (For experienced candidates :: last 3 months pay slip, latest compensation break up letter)
Assessment process - CV screening->Aptitude->HR Interview->Technical interview->Final interview
Job location - Bangalore
# of openings - Multiple.
Contact person Kavya L / A Shamshuddin

Interview Location
Quintiles
Etamin Block, Wing B, Ground floor
Prestige Tech Park II, Outer Ring Road
Sarjapur, Bangalore - 560103

Clinical Research Associate -2 - 6 Years-Mumbai

 

Job Description

• Should have minimum 2 years of core on-site monitoring experience.
• Facilitate and coordinate with investigator and site for EC submission and approval.
• Conduct site feasibility and qualification visits.
• Prepare for kick-off meetings to train vendor representatives involved if out-sourced activity for
• monitoring.
• Coordinate with investigator and sites for IM and assist PM in planning for IM
• Conduct SIVs, write SIV reports, and dispatch to sites
• Monitor sites, write monitoring visit reports and send timely monitoring follow-up letters to
• sites.
• Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
• Coordinate with data management team and investigator/site team for timely DCF resolution.
• Ensure CSR submission by investigator to EC, to regulatory authority (as applicable)
• Conduct site close-outs and write close-out reports and dispatch to sites.
• Arrange trial document archival at sites, in-house, and/or by third party as applicable.
• Revise SOPs and write new SOPs as applicable.
• Maintain and keep updated training file and CV for department records
• Assist PM in trial-related activities.

APPLY ONLINE

NH Case Processing Associate-Accenture 2 - 6 yrs Chennai

Perform single case medical assessment, including the determination of seriousness, expectedness / listedness / labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing /coding conventions.

Maintain the timely submission of expedited reports.

Support the achievement of the Therapeutic Areas case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.

Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.

Partner with Worldwide Safety Strategy and with other Worldwide Safety and Regulatory Safety Operations functional groups to monitor the safety profile of assigned products.

Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.

Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness /listedness/ labeledness, causality, and data reconciliation.

As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.

Work with the Therapeutic Area Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person.
APPLY ONLINE

Antibiotic Resistance (November 2015)

Opening with Grail Research(a Division of Integreon)- Pharma Research INTEGREON

About Grail Research
Grail Research (www.grailresearch.com) specializes in conducting strategic research including market, industry, and benchmark analyses for leading companies and investors across the globe. As part of Integreon (www.integreon.com), a leading global provider of KPO services, Grail Research offers an intellectually challenging and learning driven work environment designed around developing and delivering cutting edge research products.
Designation: Analyst Primary Responsibilities
Work with project teams and design analysis plan and most effective search strategies. Gather required information and filter relevant themes using a broad set of tools (e.g., subscription databases, the Internet, print media, company representatives, external research organizations, telephonic interviews with industry experts, etc). Utilize both secondary and primary (interview, survey) research sources and techniques
Organize, analyze, synthesize and/or summarize data and information using appropriate analytical tools. Conduct quantitative (e.g., statistical analysis, financial data analysis, etc.) and qualitative analysis (in-depth interviews, etc) as necessary
Communicate research results through the creation of structured end-products (memos, spreadsheets, reports, presentations, etc.)
Required Skills
0.6 to 3 years of relevant research experience
Strong analytical aptitude problem solving, quantitative
Strong verbal and oral communication skills
Team player and excellent interpersonal skills
Logical and creative thinker with enthusiasm and a desire to get involved at Grail Research

APPLY ONLINE

Regulatory Support for Eu/us - OTC Or Cosmetics- iMEDGlobal

Responsibility

Specific day to day responsibility of the SMP support for EMEA position includes, but not limited to:
Ensure that standards and timelines are met
Use of regulatory data base (Register) and IT tools (GSS, Optiva, Starfish)
Create and update working practices for processes used between Outsource partner & EMEA Regulatory Affairs, using a lessons learned approach
Plan and track resource levels required and used for regulatory support requested.

Experience/Qualifications

Life Science or Chemistry or Pharmacist Degree or equivalent qualification.
Experience in European Regulatory Affairs for health products. Experience with Personal Care products would be desirable.
Demonstrate excellent communication skills both oral and written.
Analytical thought

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Quality Assurance - Pharmacovigilance-Crest

6,00,000 - 8,50,000 P.A
Job Description

• Communicate with Operations and clients to ensure compliance with Project Sops and Regulatory guidelines
• Prepare for regulatory as well as client audit
• Act as Compliance / safety lead for projects
• Prepare & conduct Internal Audits
• Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with Compliance standards and policies, GVP, GDP and regulatory requirements by performing the following
• Establish and manage Annual Quality Plans approved by relevant stake holders
• Corrective and Preventive Actions (CAPA) (including RCA and deviations)- Develop local processes based on global ones to conduct root cause analysis to investigate deviations and develop CAPAs. Demonstrate that the CAPA plans required are effectively implemented, monitored and closed out.
• Auditing Ensure a Local process is in place to support Audit activities as necessary, including Health Authorities Inspections. 
• Assist with self-inspections and ensuing corrective/preventive actions
• Manage quality alerts and regulatory intelligence.
• Manage Local Training activities as necessary. 
• Ensure the maintenance of the QMS through the appropriate impact assessment and QMS Management review processes.

APPLY ONLINE

Pharma Data Entry Associate-Accenture

Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.

?Carry out all case management activities as appropriate.

?Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested

?Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios

?Ensure complete and timely forwarding of ICSR to Core

?Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.

?Consistently apply regulatory requirements and Client policies

?Analyze and monitor activities, define and implement corrective actions, where applicable.

?Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.

?Provide oversight and team mentoring on case handling aspects, data extraction, and analyses.

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Officer - Pharmacovigilance (medical Writer) 1 - 5 YearsMumbai

Job Description

1. Preparation of Aggregate Safety Reports (ASR) for regulatory submissions
2. Quality review of Aggregate Safety Reports 
3. Preparation and maintaenance of ASR tracker

APPLY ONLINE

Clinical Research, Records Management Associate (0 - 3 yrs exp)-

Walkin Interview from 19th November to 20th November from 10 AM
Job Requirements:

1. Downloading, Quality check and Indexing TMF documents

2. Importing individual documents with the help of eTMF3 

    application or preparing batch import script in case eTMF3 

    servers are down

3. Communicating any issues, queries with Trial Document

    Manager and acting on the resolution

4. Maintaining study trackersGood Communication Skills

5. MS Office knowledge

5. Willingness to work in Night Shifts

5. Min 6 months relevant experience (Mandatory) 

Location- Pune (Talawade)

Contact Details

Recruiter Name:Vishal Salve

Contact Company:Syntel Ltd

Telephone:020-30615000

Reference Id:Clinical Research

Playing it Safe With Eggs -What You Need to Know

Fresh eggs must be handled carefully to avoid the possibility of foodborne illness, often called "food poisoning." Even eggs with clean, uncracked shells may occasionally contain bacteria called Salmonella that can cause an intestinal infection.

The U.S. Food and Drug Administration (FDA) estimates that 142,000 illnesses each year are caused by consuming eggs contaminated withSalmonella. FDA has put regulations in place to help prevent contamination of eggs on the farm and during shipping and storage. But consumers play a key role in preventing illness associated with eggs. In fact, the most effective way to prevent egg-related illness is by knowing how to buy, store, handle and cook eggs — or foods that contain them — safely. Follow these safe handling tips to help protect yourself and your family. Read More

Clinical Trials and Human Subject Protection

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects.  Many countries have adopted GCP principles as laws and/or regulations.  The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.  These FDA regulations and guidance documents are accessible from this site.  International GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance are also be found here.  Finally, this site includes links to other sites relevant to the conduct of clinical trials, both nationally and internationally. Read More  

Clinical Research Associate 1 Quintiles-Bengaluru/Bangalore , Mumbai , Ahmedabad , Delhi/NCR(National Capital Region) , Chennai

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
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 as appropriate. 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. May support start-up phase.
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.
Build awareness of features and opportunities of study to site.
Collaborate and liaise with study team members for project execution support as appropriate.

APPLY ONLINE

Helping to Speed Cures and Treatments to Patients

The U.S. Food and Drug Administration is committed to helping deliver innovative, safe, and effective treatments and cures to the patients who need them as quickly as possible. To achieve this goal, we have implemented a variety of expedited review programs and are working to help shorten the development time before a product is even submitted for FDA review.

Accomplishments: Drugs

As a result of these efforts, in 2014 alone, FDA approved 51 new molecular entities and biological products (41 by our Center for Drug Evaluation and Research and 10 by our Center for Biological Evaluation and Research). These approvals included major therapeutic advances in the treatment of cancer, hepatitis C and type-2 diabetes. They also included vaccines for meningococcus type B, and more new orphan drugs for rare diseases than any previous year in our history.

Accomplishments: Devices

We’ve also made strides with medical devices. As a result of activities coordinated by CDRH Innovation, and programmatic improvements and innovative use of our existing approval and clearance pathways, many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade. Read More

FDA approves Darzalex for patients with previously treated multiple myeloma

Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and cause other bone or kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year.

“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”

Darzalex injection, given as an infusion, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.

Read More

Officer - Medical Services Glenmark Pharmaceuticals Ltd

Summary: To collect, monitor, assess and evaluate information received through Perception, Opinion & Expertise of Medical Professional studies in order to research a target market and get a feedback of our Products.
This would help to ensure that enough safety information is available on the products that we market across the globe.

PERCEPTION, OPINION & EXPERTISE OF MEDICAL PROFESSIONAL (POEM) STUDIES:

List of doctors with contact details / consent letters are received from marketing team.
Keeping track of booklet received.
Maintenance of study documents and replication of data into excel sheet.
Maintaining and updating internal database for POEM studies
Updating the marketing team on regular basis for receipt of POEM study documents
Analysis of the data after data entry is done.
Preparation of Final report
IN CLINIC DATA COLLECTION (ICDC) STUDIES:
List of doctors with contact details/ consent letters are received from marketing team
Handing over ICDC booklets over to respective doctors
Undertaking Follow ups at regular intervals to collect necessary information with respect to patient
recruitment status, adverse events and to check the progress of the study.
Collection and maintenance of Study documents after completion of the study
On receiving the completed ICDC booklets, the data is transcribed into excel sheet to prepare a database for further analysis.
Booklets with adverse events are reported to PV department
Keeping track of booklet received.
Compliance of local ICDC SOPs.
PHARMACOVIGILANCE:
Timely reporting of any adverse events to Pharmacovigilance System
Receive and track all spontaneous and clinical study cases
Forward reports to Central Processing or to Contractual partner as appropriate.
Follow up of certain cases
Source records retention
Coordinating with MIDAS (Medical Information Service) Manager for any safety information
Training of field force and maintain records of training.
Adhering to LPvRP working guidelines
Perform QC check of reported cases to contractual parties fortnightly.
Coordinating with marketing/CQA in case of Product complaints or adverse events
Coordinating with Global PV team to provide them with required information/documents

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Opening for Medical Writing/ Scientific Writing at Indegene, Bangalore

Kindly find the job description:
1.Responsible for authoring regulatory/ safety documents such as Protocol, CSR, IB, Clinical Overviews & Summaries, Subject Narratives, Aggregate Reports, RMPs and others
2.Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
3.Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards. Update SOPs and other job aids for completeness as needed



Required Skills:
1. Minimum 4 years of experience in pharmaceutical companies in any of the following functionsregulatory-medical writing/developing/publishing medical content
2. Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
3. Strong flair and passion for writing.
4. Strong written and verbal communication/presentation skills.
5. Passion for networking.
6. Being up-to-date with the latest technical/scientific developments and relating them to various projects.

M. Pharm/BDS/ MBBS/ Ph.D with 3 to 4 years of experience in Regulatory Writing

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Current status of clinical research in India

Clinical research has grown exponentially over the past decade in India because of cost advantage, treatment natïve patient, qualified doctors conversant in English etc. India was the second most preferred country to conduct clinical trials outside the US in 2009. However, recent years have witnessed a decline in number of trials in India (529 in 2010; 253 in 2012). The number of drugs entering the Indian markets had been gradually reducing even before the current slump in clinical research activity (270 in 2008;140 in 2011; 44 in 2012 and 25 in 2013). This necessitates a relook on the strategy so as to optimise clinical research in Indian context. The problems and possibilities around the clinical research arena can be broadly grouped as capacity building issues and ethico – regulatory ones.

In India, Drug Controller General (India) (DCGI) is the competent authority for approving clinical trials as well as manufacturing and marketing drugs. DCGI grants approval after appropriate clinical trials are conducted in India with adequate number of trial subjects. To begin with, there are scant training resources to train adequate number of researchers so as to carry out research activities as per the international standards. There is a need to build dynamic training modules and platforms which confirm to international regulations and best practices while addressing peculiar national needs. The training infrastructure needs to be flexible enough to accommodate ever changing regulatory landscape. We have a thriving knowledge base of traditional medicine systems which cater to a large segment of the population are regulated by a separate Department of AYUSH. There is a requirement of involving AYUSH practitioners in collaborative research and reorient the research regulations so as to effectively monitor research in AYUSH. Recent draft notification regarding regulations for ‘Phytopharmaceuticals’ is a step in this direction.

Though India has a robust regulatory apparatus, it is perceived that Indian patients being poor and less informed are vulnerable. While isolated instances of unethical clinical trials cannot be ignored, a more informed debate and perception management is the need of the hour. The confidence building amongst all stake holders has now assumed paramount importance. Read More

Career opportunities for Bio-science, Pharmacy & Medical Graduates and Post Graduates

India has become a major hub for clinical trials. Despite this, several problems related to availability of drugs, distribution, accessibility and consumption still remain at large. 

Pharmacovigilance is the discipline which takes care of such aspects and is concerned with identifying, validating, quantifying and evaluating adverse reactions associated with the use of drugs thereby improving the safety of medicines in use. 

Bio-Science, Pharma, Medical & Para Medical Graduates & Post Graduates can enter into these sector a career option. All major CRO, Bio-pharma organization, Medical Device companies, KPO, BPO and IT Life Science companies is on the move of hiring knowledgable anad certified pharmacovigilance candidates.

Now here, any aspirant who wants to join in this industry should focus in two basic issues . The first point is, developing a strong pharmacovigilance knowledge base and the second one is preparing him or herself for interview.

While making a choice of developing knowledge development, as a candidate, you need to do a certificate program in pharmacovigilance. There is no mandetory need of university approved certification or duration of program as a key factory for hiring terms & condition from leading organization, but all the hiring organization typically looks into the quality of knowledge base that a candidate have with them, so that they can use the knowledge to implement into the project management aspects directly.

So, aspirants should focus on individual goal about the learning process and content of the syllabus rather than large amount course fee, brand institutions, good infrastructure and campus etc. The chance of getting jobs after completion of the program is totally depends on the aspirants rather than the institute, institute can help the aspirants by providing best possible knowledge base and maximizing the interviewing opportunity, but the ultimate work is to perform well on the day of interview by the candidate, there is no shortcut.

Current trend is that, while selecting an institute for pharmacovigilance certification much importance are given on the content of the program than anything else. Following are some basic outline of any pharmacovigilance certification program which can help you to get jobs.  It should include like, basic principles of pharmacovigilance and clinical research, regulatory affairs environment FDA, CDSCO, EMA, management of pharmacovigilance data, risk management in pharmacovigilance and pharmacoepidemiology, may more etc. The objective should be to develop candidates who are experts at monitoring the adverse effects of the drugs which have been released in the market. Their goal should be to establish safety of the drug and oversee the well-being of the consumers.

Pharmacovigilance is still in its infancy in India, therefore higher standards of pharmacovigilance are warranted to be at par with the rest of the world in terms of not only compliance to regulations but also to implement quality systems in all pharmaceutical companies especially the generic companies which manufacture bulk drugs that are marketed in India and the Western countries. 

There is no shortage of job opportunities in this field as good pharmacovigilance practice makes for good business sense. Students of this field can get jobs in all leading CRO, Bio-Pharma organization, Medical Device companies, KPO, BPO and IT Life Science companies with attractive salaries with robust increments, world class learning and global exposure.

 

Do a pharmacovigilance certification program and get 100% placement support- click here

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

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 clinicaltrial
Ensure proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinicaltrial
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.

Should have experience working with English/Allopathy drugs

 

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Senior Medical Writer: Clinical Evaluation Report (cers) Cactus Communications

CACTUS Medical offers medical writing services to multinational biopharmaceutical and devices companies, clinicalresearch organizations, and researchers worldwide. We work with clinicians and researchers to help them communicate their science to the world. We are currently looking to add to our team, experienced medical writers who have exposure to regulatory writing as well as hands-on experience of writing on medical devices or CER writing experience, and who aspire to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.

As a CER writer in the CACTUS Medical team, you will:

• Ensure timely production of high quality CERs for devices across therapeutic areas
• Screen and summarize literature for relevant clinical data
• Review literature to elucidate the clinical problem and current treatment techniques
• Study and report device characteristics and instructions for use
• Evaluate data for similar competitor devices
• Summarize post-marketing surveillance and risk management data for the target device
• Work with senior writers to prepare documents that meet client expectations in terms of content, format, and presentation

Location: Andheri (West)

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Drug Safety Associate - Voice Process - Night Shift Synowledge PV Services India Pvt Ltd

JOB TITLE: Drug Safety Associate

LOCATION: Mysore, India

YEARS OF EXPERIENCE: 0 to 1 years

EDUCATION: Health care professional (BPharm / B Sc nursing/ BDS/ MPharma/ Pharm D) OR PostGrads in Biotechnology, Microbiology, Biochemistry,Clinical Research, Bio-Physics, Molecular Biology, Medicinal Chemistry,Nuclear Sciences, Bioinformatics

ESSENTIAL DUTIES AND RESPONSIBILITIES:
As Case Intake Member:
Responsible for case intake, duplicate check , and registration
Maintain log of source documents and other communications

As Case Processor:
Responsible for data entry of individual case safety reports into the safety database.
Review and evaluate AE case information to determine required action based on and following internal policies and procedures
Process all incoming cases in order to meet timelines
Full data entry including medical coding and safety narrative

As Medical Coder
Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)

As Narrative Writer
Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

As Literature Review Specialist
Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
Review of literature articles to identify case safety reports.
Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
Assist in signal generation and safety analysis activities.
Ensure quality of literature searches and reporting.
Review of local/global literature reports to determine regional reportability.
Create/maintain study summary documents.
Assist with narrative writing for periodic/ad hoc submissions.
Assist with ad hoc or routine safety monitoring activities.
OTHER RESPONSIBILITIES:
Following up with sites regarding outstanding queries.
Follow up on reconciliation of discrepancies.
Follow departmental AE workflow procedures
Closure and deletion of cases
Perform any other drug safety related activities as assigned
Perform literature review activities when trained and assigned.

SPECIALIZED KNOWLEDGE AND SKILLS:
Basic competence with medical and therapeutic terminology.
Ability to work independently but guided by documented procedures, with appropriate support.
Able to work effectively as part of a team.
Understanding of patient safety regulatory obligations.
Should be familiar regulatory &pharmacovigilance guidelines.
Should be familiar with pharmacovigilance terminology.
Excellent attention to detail.
Ability to deliver within established timelines.
Fluency in English and excellent comprehension.
Computer literate.

COMMUNICATION SKILLS:
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross- department communication. Ability to document and communicate problem/resolution and information/action plans.

DESIRED TECHNICAL SKILLS:
Person should be familiar with MS Office Tools.
Safety database knowledge.

OTHER SKILLS:
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.

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Opening for Quality - CDM Cognizant Technology Solutions India Ltd

Minimum of 1 years relevant experience in Clinical data management, Pharmacovigilance or equivalent clinical domain or hands on relevant QC experience. Prior experience in performing QC activities preferred.

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Clinical Research Process-Point to Point activity

It is a research environment, starts from a specific point and ends to a specific point, know more about it, apply for a research program here- https://docs.google.com/forms/d/1Zx-P5nQzNV1EFUYmkXHIXzDGJ5DPWLq1FTV0YxSRu6Y/viewform

Make this Diwali more prosperous with a Pharmacovigilance Program

Apply for a Pharmacovigilance certification program and get unlimited placement assistance until you are not being hired. Application form link-
https://docs.google.com/forms/d/1Zx-P5nQzNV1EFUYmkXHIXzDGJ5DPWLq1FTV0YxSRu6Y/viewform

Stable & good career opportunity for bio-science, pharmacy graduates and post graduates

India has become a major hub for clinical trials. Despite this, several problems related to availability of drugs, distribution, accessibility and consumption still remain at large. 

Pharmacovigilance is the discipline which takes care of such aspects and is concerned with identifying, validating, quantifying and evaluating adverse reactions associated with the use of drugs thereby improving the safety of medicines in use. 

Bio-Science, Pharma, Medical & Para Medical Graduates & Post Graduates can enter into these sector a career option. All major CRO, Bio-pharma organization, Medical Device companies, KPO, BPO and IT Life Science companies is on the move of hiring knowledgable anad certified pharmacovigilance candidates.

Now here, any aspirant who wants to join in this industry should focus in two basic issues . The first point is, developing a strong pharmacovigilance knowledge base and the second one is preparing him or herself for interview.

While making a choice of developing knowledge development, as a candidate, you need to do a certificate program in pharmacovigilance. There is no mandetory need of university approved certification or duration of program as a key factory for hiring terms & condition from leading organization, but all the hiring organization typically looks into the quality of knowledge base that a candidate have with them, so that they can use the knowledge to implement into the project management aspects directly.

So, aspirants should focus on individual goal about the learning process and content of the syllabus rather than large amount course fee, brand institutions, good infrastructure and campus etc. The chance of getting jobs after completion of the program is totally depends on the aspirants rather than the institute, institute can help the aspirants by providing best possible knowledge base and maximizing the interviewing opportunity, but the ultimate work is to perform well on the day of interview by the candidate, there is no shortcut.

Current trend is that, while selecting an institute for pharmacovigilance certification much importance are given on the content of the program than anything else. Following are some basic outline of any pharmacovigilance certification program which can help you to get jobs.  It should include like, basic principles of pharmacovigilance and clinical research, regulatory affairs environment FDA, CDSCO, EMA, management of pharmacovigilance data, risk management in pharmacovigilance and pharmacoepidemiology, may more etc. The objective should be to develop candidates who are experts at monitoring the adverse effects of the drugs which have been released in the market. Their goal should be to establish safety of the drug and oversee the well-being of the consumers.

Pharmacovigilance is still in its infancy in India, therefore higher standards of pharmacovigilance are warranted to be at par with the rest of the world in terms of not only compliance to regulations but also to implement quality systems in all pharmaceutical companies especially the generic companies which manufacture bulk drugs that are marketed in India and the Western countries. 

There is no shortage of job opportunities in this field as good pharmacovigilance practice makes for good business sense. Students of this field can get jobs in all leading CRO, Bio-Pharma organization, Medical Device companies, KPO, BPO and IT Life Science companies with attractive salaries with robust increments, world class learning and global exposure.

 

Do a pharmacovigilance certification program and get 100% placement support- click here

Pharmacovigilance Certification Program-100% Placement Assistence

Pharmacovigilance Certification Program-Application Form-Apply in the following link:
CLICK HERE-APPLICATION FORM

FDA approves new treatment for HIV

The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

The CDC estimates that 1.2 million persons ages 13 years and older are living with HIV infection, and that more than another 150,000 persons in this age range have HIV but are unaware of their infection. Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable.

“Today’s approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Genvoya is approved for use in HIV-infected adults and children ages 12 years and older weighing at least 35 kilograms (77 pounds) who have never taken HIV therapy (treatment-naïve) and HIV-infected adults whose HIV-1 virus is currently suppressed. While Genvoya is not recommended for patients with severe renal impairment, those with moderate renal impairment can take Genvoya.

Genvoya’s safety and efficacy in adults were evaluated in 3,171 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA approved HIV treatment. Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens.

Read More