Medical Director, MPMD, PSPV
Core
Provide strategic and medical leadership for global patient safety across assigned pharmaceutical and biological products, acting as the Global Safety Lead accountable for end-to-end safety strategy and benefit-risk evaluation.
Role type
Senior Medical Director, Global Safety Lead (Pharmacovigilance)
Builds
Regulator-ready safety outputs, Risk Management Plans, and safety profiles for product lifecycle management
Domain
Pharmaceutical industry, Pharmacovigilance, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Benefit-risk assessment, signal detection and management, regulatory document authorship, cross-functional team leadership, pharmacovigilance regulations knowledge, quantitative methodologies, AI for safety surveillance
Preferred skills
Board certification, active participation in continuing medical education, leveraging artificial intelligence for signal detection
Technologies
Artificial intelligence, quantitative methodologies
Responsibilities
Lead the Global Safety Team and Safety Management Team; Analyze and interpret safety data from non-clinical, clinical, and real-world evidence; Conduct signal detection, monitoring, and management; Develop strategy for responses to regulatory inquiries; Author critical documents including protocols, informed consent forms, and Risk Management Plans; Integrate safety considerations into clinical development program design; Train and mentor Pharmacovigilance Physicians and Safety Scientists
Seniority
Senior, hands-on IC with strategic leadership
