Executive Director, Drug Safety & Pharmacovigilance
About the Company
Fast-growing biopharmaceutical company
Industry
Health, Wellness and Fitness
Type
Public Company
Founded
1993
Employees
501-1000
Categories
About the Role
The Company is seeking an Executive Director for Drug Safety and Pharmacovigilance. The successful candidate will be at the forefront of ensuring the safety and efficacy of the company's products, with a focus on those in clinical development and post-marketing surveillance. This key leadership role is responsible for developing and implementing strategies to achieve pharmacovigilance and medical safety goals, as well as representing the company in communications with health authorities. The role involves assessing safety signals, managing potential safety issues, and ensuring that all activities are in compliance with regulatory requirements and company standards. The Executive Director will also be involved in the development of risk management plans and will be accountable for the medical evaluation of safety data. Candidates for this role should have an MD degree or equivalent, with a strong background in pharmacovigilance, preferably in a pharmaceutical or biotechnology setting. Experience in signal management and a background in neurology, psychiatry, or CNS-related diseases are highly desirable. The ideal candidate will have a solid understanding of FDA and EU regulations, ICH guidelines, and a proven track record of at least 15 years in drug safety, including safety leadership experience. Advanced skills in assessing product risk-benefit profiles, strong attention to detail, and the ability to work independently are essential. The role also requires excellent interpersonal, communication, and organizational skills, as well as the ability to lead and train a team.
Hiring Manager Title
Head of Safety
Travel Percent
Less than 10%
Functions
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