Manager Medical Review

Build our future together  At Regeneron, Global Patient Safety helps protect patients by ensuring safety information is evaluated with scientific rigor and documented to the highest quality standards. As Manager, Medical Review, you will join our India-based Global Patient Safety POD and lead the end-to-end medical review of Individual Case Safety Reports from global development programs and selected marketed products. Your clinical judgement will shape accurate coding, expectedness and causality decisions, clear case narratives, and inspection-ready submissions. Working closely with triage colleagues and US- and EU-based safety partners, you will help create cohesive case documentation, strengthen pharmacovigilance processes, and explore responsible uses of new technologies, including AI.  When & where  Location:Hyderabad 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.