Senior Manager Medical Review
Core
Lead medical review of safety cases to ensure scientific soundness and inspection readiness for health authority submission.
Role type
Senior Manager, Pharmacovigilance Medical Review
Builds
Global Patient Safety team supporting development programs and marketed products
Domain
Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
ICSR medical review, narrative authoring, causality assessment, expectedness determination, MedDRA coding, ICH E2A/E2B/E2D guidelines, FDA/EMA regulations, Argus Safety proficiency, clinical judgment
Preferred skills
Global development programs experience, marketed products experience, AI/generative AI tools exposure
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
