Senior Manager Medical Review
Core
Lead the medical review of safety cases (ICSRs) to ensure scientific soundness and inspection readiness for health authority submissions.
Role type
Senior Manager, Pharmacovigilance Medical Review
Builds
Inspection-ready safety documentation for global development programs and marketed products
Domain
Life Sciences / Pharmacovigilance
Required skills
Medical review of ICSRs, Causality assessment, Narrative authoring, MedDRA coding, Knowledge of ICH E2A/E2B/E2D guidelines, Proficiency with Argus Safety, Clinical judgment, SOP development, Mentoring
Preferred skills
Experience with global development programs or marketed products, Exposure to AI or generative AI tools in pharmacovigilance
Technologies
Argus Safety, MedDRA
Responsibilities
Lead end-to-end case quality from coding to final company comment, Perform and oversee medical review of ICSRs within time standards, Author and review case narratives and causality rationale, Code adverse events and medical history, Partner with triage, PV, risk management, and clinical development teams, Serve as medical resource for assigned compounds, Drive SOP development and process improvement, Mentor Managers and junior reviewers
Seniority
Senior Manager, hands-on IC with leadership