Medical Director, Patient Safety Physician
Core
Lead clinical safety strategy for high-impact therapies from development through post-marketing, guiding benefit-risk decisions and risk minimization.
Role type
Senior IC Medical Director (Patient Safety)
Builds
Safety strategies, risk management plans, regulatory submissions, and labeling updates for pharmaceutical products.
Domain
Biopharmaceuticals / Pharmacovigilance
Required skills
Medical degree (MD/MBBS), Patient Safety strategy, Risk Management Planning, Signal Detection and Evaluation, Regulatory reporting (PBRERs/PSURs), Labeling updates, Cross-functional leadership, External engagement with regulators
Preferred skills
11-13 years Patient Safety experience, 16+ years total experience, Drug Development experience, Disease and Therapeutic Area knowledge
Technologies
Pharmacovigilance systems, Safety reporting tools
Responsibilities
Own clinical safety strategy for assigned products; Review and endorse Patient Risk Management Plans; Provide strategic input to clinical development planning; Lead signal detection and evaluation activities; Provide medical input to labeling and regulatory submissions; Represent Patient Safety on cross-functional teams; Mentor junior team members in safety evaluation.
Seniority
Senior, hands-on IC with leadership responsibilities