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 to ensure patient protection and regulatory success.
Role type
Senior IC Medical Director (Patient Safety)
Builds
Global safety strategies, risk management plans, regulatory submissions, and safety information for pharmaceutical products.
Domain
Biopharmaceutical industry, clinical research, global regulatory compliance.
Required skills
Medical degree (MD/MBBS), Patient Safety strategy, Pharmacovigilance, Signal detection and evaluation, Risk management planning, Regulatory reporting (PBRERs/PSURs/DSURs), Labeling updates, Cross-functional leadership, Mentorship.
Preferred skills
Oncology or high-priority therapeutic area experience, Leadership of Safety Management Teams, Direct interaction with global regulators, Due diligence and product liability support, Mentorship of junior scientists.
Technologies
Clinical trial protocols, Investigator brochures, Safety Agreements, Global regulatory databases.
Responsibilities
Define identified and potential risks and propose mitigation measures; Review and endorse Patient Risk Management Plans; Provide strategic input to development planning and approve study documents; Lead surveillance activities including medical review of individual cases and signal detection; Provide medical input to labeling updates and regulatory reports; Represent Patient Safety on clinical and project teams; Mentor junior team members in safety reporting and risk management.
Seniority
Senior, hands-on IC with strategic leadership