Director, Safety Physician
Core
Director of Safety Physician leading medical review of individual case safety reports (ICSRs), signal detection, and aggregate safety reporting for oncology investigational and marketed products.
Role type
Senior IC safety physician (oncology)
Builds
Safety summaries (DSURs, PBRERs), regulatory responses, and safety signal evaluations for oncology trials
Domain
Biopharmaceutical oncology (immunotherapy and chemotherapy)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical review of ICSRs, signal detection, aggregate safety reporting, MedDRA coding, safety data analysis, SOP development, inspection readiness, team leadership
Preferred skills
Oncologist with practical experience
Technologies
Safety databases, technical safety systems
Responsibilities
Implement medical review of ICSRs (narratives, coding, causality), prepare Analysis of Similar Events (AOSE), lead safety presentations to Drug Safety Committees, review aggregate safety data for signals, mentor junior reviewers, maintain inspection readiness, author safety summary documents
Seniority
Director, hands-on IC with managerial responsibilities
