Overview In this role you will lead the development and execution of integrated risk management for development compounds, guiding safety strategy within the Safety Management Team framework. You will coordinate cross-functional resources and collaborate with Clinical Development, Regulatory, Project Management, Biostatistics, and Pharmacology to manage benefit-risk across the lifecycle. You will represent safety leadership on Global Product Teams and drive risk management plans from early development through commercialization. This position offers the opportunity to shape safety strategies across programs and contribute to a global healthcare mission.
Responsibilities- Lead a team of physicians and scientists, provide training and coaching, and ensure high-quality output.
- Represent CSPV on Global Product Teams and cross-functional groups as safety lead.
- Review and analyze safety data from trials and other sources to identify signals.
- Lead internal and external safety interactions with regulators and advisory bodies.
- Define and execute risk management strategies across the product lifecycle.
- Coordinate resources to deliver safety evaluation documents on time.
- Coordinate safety-related regulatory interactions (meetings, post-approval commitments).
Key requirements- MD
- Board certification or eligibility
- 6+ years in pharma, regulatory, or academia with exposure to drug development, clinical pharmacology, or epidemiology
- leadership
- excellent scientific communication
- cross-functional collaboration
- pharmacovigilance
- risk management planning
- safety signal detection and assessment
