Medical Director, Senior Patient Safety Physician
Core
Provide medical leadership for clinical safety and benefit-risk management across the lifecycle of assigned products and development programs.
Role type
Senior IC Medical Director (Clinical Safety)
Builds
Innovative medicines
Domain
Pharmaceutical/Biotechnology
Required skills
Medical Degree (MD/MBBS), Clinical practice experience, Clinical Safety/Pharmacovigilance expertise, Benefit-risk assessment, Risk management, Signal detection, Global pharmacovigilance regulations, Regulatory safety document preparation
Preferred skills
Advanced training in Pharmaceutical Medicine, Experience across multiple therapeutic areas, Leadership experience
Technologies
DSURs, PBRERs, PADERs
Responsibilities
Lead clinical safety strategy, Drive medical evaluation of safety data, Provide expert input into risk identification and mitigation, Lead interpretation of safety data from clinical trials and post-marketing experience, Lead and review key regulatory safety deliverables, Serve as Patient Safety representative in clinical project teams, Mentor colleagues
Seniority
Senior, hands-on IC with leadership responsibilities