Manager Medical Review
Core
Lead end-to-end medical review of Individual Case Safety Reports for global development programs and marketed products, ensuring accurate coding, causality decisions, and inspection-ready submissions.
Role type
Manager, Medical Review (Pharmacovigilance)
Builds
Cohesive case documentation and submission-ready safety reports for global development programs and marketed products.
Domain
Healthcare / Pharmacovigilance
Required skills
Medical review of Individual Case Safety Reports, MedDRA coding, causality assessment, expectedness determination, narrative authoring, ICH E2A/E2B/E2D guidelines knowledge, FDA/EMA regulatory requirements, Oracle Argus Safety proficiency, clinical judgment
Preferred skills
Experience in Global Patient Safety POD, insourced pharmacovigilance model, AI/generative AI tools in safety review
Responsibilities
Perform complete medical review of Individual Case Safety Reports within defined timelines, Review and strengthen case narratives and reporting decisions, Determine expectedness using current reference safety information, Apply clinically appropriate MedDRA coding, Partner with pharmacovigilance teams to produce submission-ready documentation, Serve as a medical resource for assigned compounds
Seniority
Manager, hands-on IC