Executive Director, Drug Safety
About the Company
Leading pharmaceutical company specializing in drug manufacturing & research services
Industry
Pharmaceuticals
Type
Public Company
Founded
2020
Employees
10,001+
Categories
Specialties
About the Role
The Company is seeking an Executive Director for Drug Safety. This strategic leadership role is accountable for defining and executing the safety strategy and procedures for an assigned therapeutic area product portfolio. The successful candidate will be responsible for post-marketing pharmacovigilance activities, including safety surveillance in both interventional and non-interventional studies, and ensuring the scientific safety assessment of products aligns with patient safety and benefit-risk decision-making. The role involves leading interactions on product safety with governance committees and regulatory agencies, building strong cross-functional relationships, and providing leadership in safety-related decision-making bodies. Additionally, the Executive Director will be involved in business process ownership, line management, staff development, and ensuring compliance with global drug safety regulations. Applicants must have a Medical Degree, with a preference for clinical experience in relevant specialties, and at least 10 years in the pharmaceutical industry, with 5-10 years in global drug safety and pharmacovigilance. Extensive knowledge of PV standards, processes, and global regulations is essential, as is experience in pharmacoepidemiology and benefit-risk management. The role requires excellent communication, analytical, and leadership skills, the ability to build and maintain strong customer-focused relationships, and a proactive, detail-oriented approach. Experience in women's health is a plus. The ideal candidate will be a team player, with a proven track record of managing people, and the ability to work in a highly networked, diverse, and dynamic environment.
Hiring Manager Title
Vice President, Regulatory Affairs
Travel Percent
Less than 10%
Functions
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