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

APPLY ONLINE

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

Read More

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.

Read More

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.”

Read More

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.

Read More

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

APPLY ONLINE