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 safety documents (DSURs, Safety Summaries), and safety analyses for oncology clinical trials.
Domain
Pharmaceutical industry, Oncology, Clinical Drug Safety
Required skills
Medical expertise and judgement, Safety signal detection, Risk management, Regulatory reporting (EU/FDA), ICH Guidelines knowledge, Protocol design review, SOP development
Preferred skills
Experience with biologics, Global trial experience
Technologies
CatalYm Safety System, ICH Guidelines, EU/FDA reporting frameworks
Responsibilities
Lead Signal Detection process, Perform medical review of serious adverse event reports, Provide medical expertise for trial protocol design and safety analyses, Create and update development risk management plans, Oversee Safety Data Exchange Agreements, Develop relevant SOPs and guidelines
Seniority
Senior, hands-on IC