Vice President of Drug Safety
About the Company
Ambitious biopharmaceutical company specializing in treatments for rare diseases
Industry
Pharmaceuticals
Type
Public Company
Founded
2002
Employees
51-200
Specialties
About the Role
The Company is seeking a Vice President of Drug Safety to lead and oversee all drug safety operations within its development and commercial portfolio. The successful candidate will be responsible for the strategic and operational leadership of drug safety capabilities, ensuring alignment with regulations and corporate goals. This role involves managing a multidisciplinary team, including internal specialists and external vendors, and requires a strong background in pharmacovigilance, with a focus on rare and neuromuscular diseases. The VP will be tasked with developing and executing a strategic vision for the drug safety function, leading PV operations, and overseeing the preparation and submission of safety reports to health authorities. Additionally, the role includes leading benefit-risk assessments, designing risk management strategies, and providing subject matter expertise during health authority interactions. Candidates for the VP of Drug Safety position at the company should have an MD in a relevant clinical or scientific field, with a minimum of 15 years' of pharmacovigilance experience in the biopharmaceutical industry. A proven track record in senior leadership roles, particularly in safety operations across clinical development and post-marketing, is essential. The role requires deep knowledge of GCP and pharmacovigilance regulations, experience with safety databases, and strong clinical judgment. The ideal candidate will have excellent organizational and interpersonal skills, the ability to mentor high-performing teams, and a demonstrated ability to operate effectively in a fast-paced, biotechnology environment. Responsibilities also include driving inspection readiness efforts, managing vendor partnerships, and collaborating cross-functionally to align safety strategy with product development and lifecycle plans.
Hiring Manager Title
Chief Medical Officer
Travel Percent
Less than 10%
Functions
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