Senior Director, Drug Safety & Pharmacovigilance

Senior Director, Drug Safety & Pharmacovigilance

About the Company

Well-funded clinical-stage biotechnology company advancing a broad pipeline across 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 and oversee global safety and pharmacovigilance activities. The successful candidate will be responsible for ensuring compliance with all regulatory requirements and guidance, leading the oversight of adverse event case processing, and providing leadership on safety inputs across clinical and regulatory documents. This role involves close partnership 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 involved in vendor management, driving continuous improvement of PV systems, and supporting regulatory interactions. Applicants for the Senior Director position 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 provide oversight and leadership to safety personnel, support performance and development, and foster a high-performing team environment. The ideal candidate will have a proven track record in safety and PV, with the ability to partner cross-functionally and contribute to the development and maintenance of key safety documents. A strong focus on continuous improvement, scalability, and operational efficiency is essential, as is the ability to influence strategy and shape processes in a highly collaborative, science-driven environment.

Travel Percent
Less than 10%

Functions

• Medical Care/Hospital Administration
• Operations