Executive Director of Drug Safety and Pharmacovigilance
About the Company
Industry shaping pharmaceutical company
Industry
Pharmaceuticals
Type
Privately Held
About the Role
The Company is seeking an Executive Director of Drug Safety and Pharmacovigilance to lead and oversee all initiatives in this critical area. The successful candidate will be responsible for ensuring compliance with regulatory standards, maintaining patient safety, and driving the development and implementation of safety strategies for pharmaceutical products. This role involves providing medical expertise in the evaluation of safety data, representing the organization in interactions with regulatory agencies, and leading continuous improvement in safety processes. The Executive Director will also be tasked with contributing to the strategic direction of the pharmacovigilance department and supporting the development and training of the safety team. Applicants must have a Doctor of Medicine (MD) degree, a minimum of 11 years' experience in drug safety and pharmacovigilance, and executive-level experience in managing safety teams and processes. Key responsibilities include overseeing the collection, analysis, and reporting of adverse event data, developing and maintaining risk management plans, and ensuring timely submission of safety reports to regulatory agencies. The role requires a strong knowledge of regulatory requirements and industry standards, the ability to lead cross-functional teams, and excellent communication and presentation skills. A commitment to high ethical standards and patient safety is essential, as is experience with risk management and safety monitoring systems.
Travel Percent
Less than 10%
Functions
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