Hybrid Pharmacovigilance Job at Regeneron, Hyderabad | Medical Review Manager Job Opportunity!

About the role

This Hybrid Pharmacovigilance Job opportunity in Hyderabad allows you to lead medical safety case reviews, collaborate with global development teams, and contribute to life-changing medicines.

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