Senior Manager Medical Review

Responsibilities

• Act as team lead, owning end-to-end case quality from coding through causality to final company comment
• Perform and oversee medical review of ICSRs within defined time standards, ensuring accuracy in Argus
• Author and review case narratives, analysis of similar events, and company causality rationale
• Code adverse events and medical history using MedDRA in line with global safety standards
• Partner with triage, PV, risk management, and clinical development teams on inspection-ready documentation
• Serve as the medical resource for assigned compounds, resolving and escalating complex case issues
• Drive SOP development, process improvement, and integration of new technologies including AI
• Mentor Managers and junior reviewers to ensure consistent application of medical and regulatory standards

Requirements

• MD or MBBS with active registration (or eligibility for registration) with the relevant Indian professional regulatory body
• Minimum 8–10 years of pharmacovigilance experience with hands-on ICSR medical review, including narrative authoring, causality assessment, and expectedness determination
• Strong knowledge of ICH E2A, E2B, and E2D guidelines and FDA/EMA pharmacovigilance regulations
• Proficiency with Argus Safety or an equivalent safety database and MedDRA coding
• Sound clinical judgment with the ability to assess complex cases and communicate reasoning clearly in writing

Preferred Qualifications

• Experience within global development programs or on marketed products
• Exposure to AI or generative AI tools in pharmacovigilance or clinical documentation

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development.