Executive Director, Pharmacovigilance and Drug Safety, Operations and Systems
About the Company
Emerging biopharmaceutical company
Industry
Biotechnology
Type
Public Company
Founded
1996
Employees
201-500
Categories
Specialties
About the Role
The Company is in search of an Executive Director for Pharmacovigilance and Drug Safety, with a focus on Operations and Systems. The successful candidate will be a key leader in building and managing the Pharmacovigilance Operations, Systems, and Compliance team. This role is pivotal in ensuring the safety and compliance of the company's products throughout their lifecycle, from first-in-human to post-marketing. The Executive Director will be responsible for all aspects of PV operations, including maintaining the global safety database, generating safety reports, and implementing pharmacovigilance systems that comply with global regulations. They will also oversee the process of identifying and managing outsourcing safety vendors, as well as leading the team in preparation for and response to inspections by regulatory authorities. Applicants must have a Health Care Professional degree, with a Master's level degree in a related field preferred, and at least 15 years of experience in PV operations within global pharmaceutical or biotechnology companies. A strong background in ICSR management, aggregate safety reporting, and a proven track record in safety informatics is essential. The role requires extensive knowledge of US and global safety regulations, excellent negotiation and decision-making skills, and the ability to lead a team in a dynamic, fast-paced environment. The ideal candidate will have a history of enhancing PV operations and compliance solutions, ensuring audit and inspection readiness, and a demonstrated ability to deliver projects on time and within budget. Strong communication, time management, and the ability to work collaboratively with both internal and external partners are also key qualifications for this position.
Hiring Manager Title
Senior Vice President, Pharmacovigilance and Safety Officer
Travel Percent
Less than 10%
Functions