Director, Safety Physician
Core
Lead medical review of individual case safety reports (ICSRs), prepare Analyses of Similar Events (AOSEs), and provide strategic input on adverse event monitoring and signal detection for investigational and marketed oncology products.
Role type
Director, Safety Physician (Pharmacovigilance)
Builds
Safety reports, signal detection analyses, and safety information for regulatory and internal committees
Domain
Biopharmaceutical oncology (Non-small Cell Lung Cancer, Colorectal Cancer)
Deliverable
client delivery
Required skills
Medical review of ICSRs, causality assessment, signal detection, safety database analysis, protocol review, regulatory compliance
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead medical review of ICSRs including narratives, coding, expectedness, causality, and seriousness assessments; Prepare Analyses of Similar Events (AOSEs) to support IND safety reports; Confirm criteria and content for expedited safety reporting and unblinding decisions; Lead or contribute to safety information preparation for Drug Safety Committee, Product Safety Review Team, and Independent Data Monitoring Committees; Review study protocols for safety-related content accuracy and overlapping toxicities; Interact with pharmacovigilance vendor medical reviewers and company Medical Monitors; Review individual and aggregate safety data to support signal detection; Serve as product lead and/or therapeutic area lead; Identify and communicate ICSR case quality issues to PV Operations.
Seniority
Director, strategic oversight & mentorship
