Senior Medical Safety Specialist

2 weeks ago


Pune, Maharashtra, India EVERSANA Full time
Job Description

Eversana is seeking a skilled Medical Reviewer to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs). The successful candidate will assist clients with safety data, compliance with pharmacovigilance legislation and guidance, and all medical aspects of pharmacovigilance.

Key Responsibilities:
  • Medical Review and Analysis: 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.
  • Regulatory Compliance: Assist clients with compliance with pharmacovigilance legislation and guidance.
  • Internal Consulting: Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
  • Product Knowledge: Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
  • Process Improvement: Involve in process improvement activities, such as implementation of quality control processes.
Requirements:
  • Education: MBBS/MD/BDS/MDS
  • Experience: 1-2 years of experience as a Medical Reviewer for ICSRs in the pharmaceutical, biotech, or medical device industries
  • Regulatory Knowledge: Knowledge of international guidelines and country-specific regulatory requirements
  • Communication Skills: Excellent interpersonal and organizational skills, with excellent written and verbal communication skills
About Eversana:

Eversana is a certified Great Place to Work across the globe. We're committed to creating a healthier world by delivering next-generation commercialization services to the life sciences industry. We value diversity, equity, and inclusion and are an Equal Opportunity Employer.



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