Head of Drug Safety & Pharmacovigilance
About the Company
Clinical-stage biopharmaceutical company focused on building the future of oncological therapy.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a Head of Drug Safety and Pharmacovigilance to provide strategic leadership and oversight of all safety and pharmacovigilance activities. The successful candidate will be responsible for ensuring compliance with US and global pharmacovigilance regulations, leading the medical review of safety cases, and maintaining a robust signal detection process. This role requires a strong background in safety governance, proactive benefit-risk assessments, and representation of PV in communications with health and regulatory authorities. The Head of Safety will also be involved in the design and implementation of risk management plans, as well as serving as a subject matter expert for drug safety-related regulatory reports and clinical study documents. Applicants must have a clinical degree (RN, PharmD, MD/DO) with at least 15 years of industry experience, including a significant background in PV for both clinical development and post-marketed products. Extensive experience with US health authorities in safety and pharmacovigilance, as well as a proven track record in leading and managing high-performing teams, is essential. The role demands excellent scientific, clinical, and analytical skills, in-depth knowledge of safety science and operations, and the ability to effectively interact with cross-functional partners. The Head of Safety will be expected to work in alignment with the company's core values and policies, and to demonstrate a strong commitment to science and patient care.
Hiring Manager Title
Chief Medical Officer
Functions
Head of Drug Safety & Pharmacovigilance • Boston, MA, United States
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