Manager Medical Review

Discover your role

• Perform complete medical review of Individual Case Safety Reports within defined timelines, ensuring clinically important information is accurately captured.
• Review and strengthen case narratives, analyses of similar events, company causality rationales, and reporting decisions.
• Determine expectedness using current reference safety information, including investigator brochures, US prescribing information, and summaries of product characteristics.
• Apply clinically appropriate MedDRA coding to adverse events and medical histories in line with Global Patient Safety standards.
• Partner with pharmacovigilance teams, risk management leads, and clinical development leads to produce cohesive, submission-ready case documentation.
• Serve as a medical resource for assigned Regeneron compounds, resolve case-level questions, and escalate complex issues when needed.
• Contribute to standard operating procedures, process improvements, and inspection-readiness activities across Global Patient Safety.
• Explore innovative ways to improve core activities through new technologies, including AI and generative AI.

This role requires

• An MD or MBBS, with active registration or eligibility for registration with the relevant Indian professional regulatory body.
• 7-9 years of pharmacovigilance experience, including hands-on medical review of Individual Case Safety Reports.
• Demonstrated experience in narrative authoring, MedDRA coding, causality assessment, and expectedness determination.
• Strong knowledge of ICH E2A, E2B, and E2D guidelines, along with FDA and EMA pharmacovigilance requirements for case processing and expedited reporting.
• Proficiency with Oracle Argus Safety or an equivalent safety database, supported by sound clinical judgement and clear written reasoning.
• The ability to work independently while collaborating effectively with global, cross-functional partners.
• Experience supporting global development programs or marketed products.
• Experience in a Global Patient Safety POD, insourced pharmacovigilance model, or similar integrated operating structure.
• Exposure to AI or generative AI tools in pharmacovigilance, safety review, or clinical documentation.