Senior Medical Director, Drug Safety
Confidential - Indianapolis, IN
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Senior Medical Director, Drug SafetyAbout the Company A prestigious biopharmaceutical company committed to innovative healthcare solutions. Industry Biotechnology Type Privately Held, Private Equity-backedAbout the Role We are on the lookout for a highly qualified Senior Medical Director for Drug Safety. In this critical role, you will lead the assessment and interpretation of safety data from diverse sources, including clinical trials and reporting systems. You will provide invaluable medical expertise in the creation of safety reports, oversee a team of dedicated medical safety professionals and pharmacovigilance scientists, and ensure adherence to drug safety regulations and standards. You will be responsible for the effective oversight of safety surveillance processes, development of comprehensive risk management plans, and delivering training to staff on safety and pharmacovigilance best practices. To be considered, candidates must possess a Medical Degree (MD) and bring at least 8 years of robust experience in drug safety or pharmacovigilance from the pharmaceutical, biotech, clinical research organization (CRO), or regulatory agency sectors. This role requires a deep understanding of US and EU drug safety regulations, CIOMS, and ICH guidelines, along with a proven track record in managing medical professionals and pharmacovigilance scientists. Proficiency in the medical review of safety data, including Individual Case Safety Reports (ICSRs) and aggregate reports, is essential. The ideal candidate will demonstrate a history of effective safety data collection, analysis, and crafting responses to regulatory authorities. Strong leadership, communication, and problem-solving skills are paramount, as well as the ability to thrive in a dynamic, fast-paced environment. Hiring Manager Title SVP, Global PV & Risk Management Travel Percent Less than 10% Functions Medical Care/Hospital Administration
Created: 2026-03-10