Senior Director, Drug Safety & Pharmacovigilance

Senior Director, Drug Safety & Pharmacovigilance

About the Company

A well-funded, clinical-stage biotechnology company focused on autoimmune and inflammatory diseases.

Industry
Biotechnology

Type
Privately Held, VC-backed

About the Role

The Company is seeking a Senior Director of Drug Safety and Pharmacovigilance to lead global safety and pharmacovigilance activities, ensuring compliance with all regulatory requirements and guidance. The successful candidate will be responsible for the oversight of adverse event case processing, aggregate safety reporting, and providing leadership on safety inputs across clinical and regulatory documents. This role involves close collaboration with clinical leads and medical monitors, serving as the primary point of contact for safety and PV-related matters, and leading the development and optimization of safety processes. The Senior Director will also be tasked with overseeing safety/PV vendors, driving continuous improvement of PV systems, and supporting regulatory interactions. Applicants must have an M.D. or foreign equivalent, with a minimum of 5 years of industry experience in pharmacovigilance. The role requires a leader who can ensure high-quality, timely submissions to regulatory agencies and stakeholders, and who is adept at partnering cross-functionally to support integrated program execution. The ideal candidate will have a proven track record in safety personnel management, be adept at supporting performance and development, and be committed to fostering a high-performing team environment. Experience in overseeing safety/PV vendors, and a strong background in safety document development and maintenance, including core data sheets, labeling, and risk management plans, are essential. The position is suited to individuals who are looking to make a significant impact in a high-growth, science-driven environment.

Functions

• Medical Care/Hospital Administration
• Operations