Vice President of Drug Safety

About the Company

Clinical stage biotechnology company advancing novel therapeutic candidates for autoimmune and inflammatory diseases.

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is seeking a Vice President of Drug Safety to lead the global strategy and execution of all safety surveillance, risk management, and regulatory compliance activities across the product lifecycle. The successful candidate will be responsible for defining and implementing the global pharmacovigilance and drug safety strategy, chairing the safety committee, and ensuring alignment with corporate priorities and clinical development objectives. This role involves designing and evolving a scalable pharmacovigilance operating model, maintaining global safety reporting infrastructure, and overseeing end-to-end safety operations. The VP will also lead the development and execution of risk management plans, ensure inspection readiness, and serve as the primary senior safety authority for regulatory interactions.
Applicants must have an advanced degree (MD, PharmD, PhD, or equivalent) and at least 10 years' of experience in pharmacovigilance, drug safety, or clinical safety, with a minimum of 5 years in a leadership role. Deep expertise in global pharmacovigilance regulations, safety reporting requirements, and risk management frameworks is essential, as is experience in immunology, autoimmune, inflammatory, or rare diseases. The role requires a strong understanding of safety databases and tools, including ARGUS, and a proven track record in managing post-marketing product safety in major territories. The ideal candidate will have direct experience with major regulatory filings and be adept at representing and articulating benefit-risk assessments to regulatory agencies. Line management experience and the ability to build and grow teams in a fast-paced, matrixed environment are also key requirements.

Functions
• Operations
• Data Management/Analytics