Vice President, Global Head of Drug Safety & Pharmacovigilance
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Vice President, Global Head of Drug Safety & Pharmacovigilance
About the Role
Greater Boston, MA Area (Hybrid)
The Company is seeking a Vice President, Global Head of Drug Safety and Pharmacovigilance to lead the strategic and operational aspects of safety for its clinical-stage programs. The successful candidate will be responsible for developing and implementing safety strategies across the portfolio, from early development to global registration. This role involves providing medical oversight for safety activities, leading risk management, and ensuring compliance with global PV regulations. The VP will also be tasked with building and leading a global safety function, including operations, compliance, and medical teams, and establishing a scalable safety infrastructure. Cross-functional leadership is essential, as the role requires close collaboration with clinical development, medical affairs, regulatory, quality, and biometrics teams. Applicants must have an MD with a minimum of 12 years' experience in drug safety, pharmacovigilance, and risk management within the biopharma industry. A proven track record in a leadership role, including experience in late-stage clinical development and regulatory submissions, is required. The ideal candidate will have deep expertise in global PV regulations, safety surveillance, and risk management, as well as a history of successful interactions with health authorities. Leadership attributes such as being patient-centered, a hands-on builder, and a collaborative partner are also key. Experience with biologics, rare diseases, and a background in taking a safety organization from clinical-stage to commercial readiness are preferred.
Functions:
- Operations
About the Company
Well-funded clinical-stage biotechnology company developing novel biologic therapies for serious diseases.
Industry
Biotechnology
Type
Privately Held
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