Director, Medical Safety
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Insmed seeks a Director of Medical Safety to lead a pharmacovigilance team overseeing signal detection, risk management, and safety reporting across the product lifecycle. This role requires strategic oversight of safety surveillance activities, compliance with global regulations, and collaboration across clinical, regulatory, and quality functions.
Responsibilities
- Lead, mentor, and develop a team of Pharmacovigilance Scientists on signal detection and risk management activities
- Oversee scientific quality of signal evaluations, Risk Management Plans, and aggregate safety reports across product lifecycle
- Provide pharmacovigilance support to clinical development programs and partner with Medical Safety Physicians on safety data evaluation
- Ensure compliance with global pharmacovigilance regulations and support regulatory inspections, audits, and submissions
- Evaluate and implement AI-enabled tools to optimize signal detection, reporting workflows, and operational efficiency
Requirements
- Master's degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or related discipline
- 10+ years pharma/biotech industry experience with minimum 5 years direct people management of PV or medical safety professionals
- Extensive signal detection and signal management experience
- Thorough knowledge of ICH guidelines, FDA, EMA, and global pharmacovigilance regulations
- Demonstrated experience authoring and managing Risk Management Plans and aggregate safety reports
- Strong leadership, scientific, analytical, and project management skills with cross-functional influence
- Understanding of AI, automation, and advanced analytics applications in pharmacovigilance
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