Sr Medical Director Risk Management, Global Pharmacovigilance
Core
Strategic leadership for global product safety risk management, benefit-risk evaluation, and safety signal governance across the product lifecycle.
Role type
Senior Director, Global Pharmacovigilance Risk Management
Builds
Global risk management frameworks, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and safety signal analytics.
Domain
Healthcare / Medical Technology / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced clinical degree (MD, DO, NP, PA, PharmD, MPH, PhD), Global PV experience, Benefit-risk assessment, Regulatory compliance (FDA, EU, ICH), Safety signal evaluation, Epidemiological insights, Risk minimization strategy, Aggregate safety reporting (DSUR, PBRER), Cross-functional collaboration
Preferred skills
Global experience, REMS experience, Safety signal presentation skills
Technologies
None explicitly stated
Responsibilities
Lead governance framework for safety risk communication to PSRB and QMR; Develop and manage Risk Management Plans (RMPs) and regulatory documents; Oversee post-authorization safety commitments (PASS) and REMS design; Provide strategic oversight for safety signal detection and validation; Contribute to regulatory submissions (MAA, NDA, BLA); Oversee aggregate safety reports (DSURs, PBRERs); Provide epidemiological insights for benefit-risk assessment.
Seniority
Senior Director, Strategic Leadership
