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/Pharmacovigilance)
Builds
Global regulatory safety deliverables (DSURs, PBRERs, PADERs) and risk minimization strategies
Domain
Pharmaceutical/Biotechnology industry, Clinical Safety, Pharmacovigilance
Required skills
Medical Degree (MD/MBBS), Clinical practice experience, Clinical Safety/Pharmacovigilance expertise, Benefit-risk assessment, Signal detection, Global pharmacovigilance regulations, Regulatory safety document preparation
Preferred skills
Advanced training in Pharmaceutical Medicine, Experience across multiple therapeutic areas, Leadership/mentoring experience
Technologies
DSURs, PBRERs, PADERs, Clinical trial data, Post-marketing data
Responsibilities
Lead clinical safety strategy and benefit-risk assessments, Provide medical oversight of signal detection and safety surveillance, Lead interpretation of safety data from trials and post-marketing experience, Lead and review key regulatory safety deliverables, Serve as Patient Safety representative in clinical project teams, Mentor colleagues in safety science
Seniority
Senior, hands-on IC with leadership responsibilities