About the CompanyA well-funded, clinical-stage biotech focused on developing next-generation immune-based therapies for autoimmune diseases. The team is working on novel approaches designed to improve patient outcomes and expand access to treatment.The RoleSenior Director, Pharmacovigilance (PV)This is a high-impact, build-stage role where you'll lead and own the safety function across clinical programs. You'll work closely with clinical and executive leadership, balancing hands-on execution with strategic oversight.What You'll Be DoingLead global pharmacovigilance activities across clinical programsOversee case processing (ICSRs) and aggregate reporting (DSURs)Provide safety input into clinical and regulatory documentsPartner closely with clinical, medical, and regulatory teamsManage vendors/CROs and external partnersBuild and improve PV processes, SOPs, and systemsSupport regulatory interactions and inspectionsWhat They're Looking ForStrong background in drug safety / pharmacovigilance (biotech or pharma)Clinical-stage experience (Phase II-III preferred)Healthcare background (physician, PharmD, etc.)Solid understanding of global PV regulations and reportingComfortable in a hands-on, fast-paced environmentWhy It's InterestingHigh visibility role with leadership exposureOpportunity to build and shape the PV functionCollaborative, low-ego team environmentWell-funded with strong momentum