Senior Safety Physician
Core
Lead strategic direction for Clinical Drug Safety, overseeing safety profile evaluation and implementing safety standards for clinical development programs.
Role type
Senior Safety Physician (Clinical Drug Safety Lead)
Builds
Safety strategies, risk management plans, regulatory submissions, and safety systems for oncology immunotherapy programs.
Domain
Biotechnology / Oncology / Clinical Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical expertise and judgement, safety signal detection, risk management, regulatory framework knowledge, SOP development, safety data exchange management, protocol design review, safety analysis leadership
Preferred skills
Experience with biologics, familiarity with ICH Guidelines and ICHE6(R3), knowledge of EU and FDA safety reporting requirements
Technologies
DSURs, Safety Summaries, Overviews, Safety Data Exchange Agreements, Quality Management Systems
Responsibilities
Provide medical expertise in safety surveillance and periodic safety reports, evaluate and manage project risks, lead signal detection processes, review serious adverse event reports, oversee Safety Data Exchange Agreements, respond to safety queries from regulatory authorities, provide input on trial protocols and reports, develop safety SOPs and guidelines, own the Safety System within the Quality Management System
Seniority
Senior, hands-on IC with strategic oversight
