Vice President and Global Head of Drug Safety and Pharmacovigilance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Vice President and Global Head of Drug Safety and Pharmacovigilance (DSPV) to help us expand what’s possible for patients with serious diseases. Reporting to the Chief Medical Officer, the Vice President and Global Head of DSPV will lead the global pharmacovigilance team to improve patients' lives and drive Insmed's overall mission through robust safety evaluation expertise and medical innovation. This role is responsible for ensuring optimal patient safety as the first priority by developing state-of-the-art safety strategy, driving medical safety processes and capabilities, and maintaining full accountability for safety compliance across all global markets. The incumbent will provide leadership and oversight of the entire DSPV organization, including Medical Safety, EMEA QPPV operations, Japan PV operations, and DSPV Operational Excellence and Compliance functions. A key priority for this leader is the delivery of an enterprise-wide strategic initiative to transform Insmed's global PV infrastructure, processes, and technology ecosystem to be best in class. What You'll Do: In this role, you’ll have the opportunity to set strategic direction for the global DSPV organization and develop & execute a multi-year PV roadmap aligned with Insmed's pipeline and commercial growth.  You’ll also have responsibilities across: Strategic Leadership Lead enterprise transformation programs, including a current strategic initiative, ensuring stakeholder alignment and full implementation. Attract, develop, and retain top PV talent to build a high-performing, globally diverse team. Represent Insmed externally at regulatory forums, industry associations, and scientific conferences. Safety Science & Medical Oversight Oversee global safety surveillance, signal detection, and risk management for all Insmed products. Ensure timely, high-quality medical safety deliverables and benefit-risk communications aligned with FDA, EMA, and PMDA frameworks. Champion integration of AI/ML, advanced analytics, and real-world evidence into PV workflows. Maintain deep expertise in rare disease safety science, including small patient population signal detection. Global Regulatory Compliance Ensure compliance with global PV regulations (GCP, GVP, GMP, ICH) across all markets; maintain inspection readiness. Support the EU/UK QPPV and oversee EMEA and Japan PV operations. Lead REMS and global Risk Management Plan (RMP) development and negotiation. Represent DSPV in interactions with FDA, EMA, PMDA, and other health authorities. Operational Excellence & Digital Innovation Drive implementation of an enterprise-wide strategic initiative, including PV system modernization and global workflow standardization. Govern a PV Technology and Innovation roadmap; evaluate and implement next-generation safety platforms and AI-assisted tools. Develop and track DSPV KPIs and quality metrics; manage global PV budget and vendor ecosystem. Ensure business continuity for all critical PV processes. Cross-Functional & External Engagement Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Commercial, Quality, and Legal/Compliance. Serve as executive sponsor and cross-functional liaison for the enterprise-wide strategic initiative. Engage with patient advocacy organizations, rare disease consortia, and industry working groups (DIA, ISOP, BIO, EFPIA). Who You Are: You must have an MD with 15+ years of drug development experience within a pharmaceutical or biotech company, 10+ years of pharmacovigilance (PV)/drug safety leadership, and a minimum of 5 years’ experience as a VP or equivalent with full PV organizational accountability.  Additionally, you have: Demonstrated experience as the head of a global PV organization, with ownership of safety strategy, compliance, operations, and team performance. A proven track record building, scaling, and transforming PV organizations through periods of significant change. 4+ years post-doctoral clinical experience. FDA and EMA inspection leadership; experience as or supporting EU/UK QPPV. Experience leading large-scale PV transformation or technology modernization programs and familiarity with AI/ML applications in pharmacovigilance. Experience with BLA/NDA/MAA/JNDA submissions and health authority interactions (FDA, EMA, PMDA). Exceptional executive leadership ability to inspire, coach, and develop globally distributed teams. Proven ability to lead through influence; demonstrated executive gravitas and leadership presence. Strong negotiation, conflict management, and cross-functional collaboration skills. Financial acumen to drive global budget management, vendor governance, and KPI development. Excellent communication; able to present complex safety data to Boards, health authorities, and senior leadership. Proficiency in PV databases (ARISg, Oracle Argus, Veeva Vault Safety), MedDRA coding, and Microsoft Office Suite. A commitment to inclusive leadership and diverse, equitable team building. Nice to have (but not required): Specialty Board Certification. An advanced degree, in addition to an MD, in Pharmaceutical Medicine, Epidemiology/Public Health, or Regulatory Science is strongly preferred. Rar