Executive Medical Director, Drug Safety
About the Company
Highly regarded biopharmaceutical company
Industry
Biotechnology
Type
Privately Held, Private Equity-backed
About the Role
The Company is seeking an Executive Medical Director for Drug Safety. The successful candidate will be responsible for the assessment and interpretation of safety data from various sources, including clinical trials and reports. This role involves providing medical expertise in the generation of safety reports, managing a team of medical safety professionals and PV scientists, and ensuring compliance with drug safety and pharmacovigilance regulations. The Executive Medical Director will also be involved in the oversight of safety surveillance processes, the development of risk management plans, and the training of staff in safety and pharmacovigilance. Applicants must have a Medical Degree (MD) and a minimum of 8 years' experience in drug safety or pharmacovigilance within the pharmaceutical, biotech, CRO, or regulatory agency. The role requires a strong knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines, as well as experience in managing medical professionals and PV scientists. Proficiency in medical review of safety data, including ICSRs and aggregate reports, is essential. The ideal candidate will have a proven track record in safety data collection, interpretation, and the preparation of responses to regulatory authorities. Strong leadership, communication, and problem-solving skills are also necessary, along with the ability to work in a fast-paced, dynamic environment.
Hiring Manager Title
SVP, Global PV & Risk Management
Travel Percent
Less than 10%
Functions
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