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(Only 24h Left) Associate Medical Reviewer

1 month ago

India EVERSANA Full time

Job Description

JOB DESCRIPTION: The most important aspect of this position is to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), assisting clients with the safety data, compliance with pharmacovigilance (PV) legislation and guidance, and all medical aspects of PV.

KEY RESPONSIBILITIES FOR THIS ROLE:

Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary within the stipulated time to comply with service level agreements and regulatory timelines.

Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.

Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.

Deep understanding of the scientific basis for therapies and drug-induced diseases. Knowledge of medical device, vaccines, and drug development process.

Acquire and maintain current knowledge of product portfolio and safety profiles for products Associate Medical Reviewer Global Lead Medical Reviewer, Associate Medical Director, Medical Director

Job Description Template

Involve in process improvement activities such as implementation of quality control process.

Provide timely feedback to case processors on the errors/discrepancies noted.

Participate in organizational activities to meet objectives suitable for the role/area of expertise.

Maintain awareness of medical-safety-regulatory industry developments

Additional responsibility could include o Provide inputs to medical writers and do medical review of various global regulatory aggregate safety reports including PADER, PBRER, ACO, PSUR. o Should be aware of end-to-end signal management process. o Provide inputs to medical write and help prepare safety evaluation report.

o Take part in signal management committee meetings

EDUCATION AND EXPERIENCE:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. MBBS/MD or comparable education

BDS/MDS with minimum of 3-4 years of experience in pharmacovigilance.

Excellent interpersonal and organizational skills.

Excellent written and verbal communication skills.

Must have hands on experience with MS Office applications (Outlook, Excel, Word, PowerPoint, etc.).