Senior Director, Safety Physician

Senior Medical Director, Pharmacovigilance - Rare Genetic Disease A rare opportunity to build something from the ground up. A late-stage, well-funded biotech with a very promising asset in Phase 3 is looking for a Senior Medical Director to lead pharmacovigilance as it prepares for its first commercial launch.This is not a seat-warming role. You'll build the medical safety function - the causality frameworks, signal detection methodology, ICSR governance - ahead of what is expected to be a high-touch, high-complexity post-marketing environment. A complex drug delivery, paediatric rare disease patients, and a company that treats patient safety as its guiding principle.What you'll ownMedical case review and causality assessment across clinical and post-marketing settingsSignal detection and management programme, including the signal detection plan and disproportionality analysisChairing the internal Safety Review Committee (ISRC)Medical input into DSURs, PSURs, PBRERs and NDA/MAA safety summariesCross-functional safety advocacy - from clinical development to commercial and medical affairsWhat they're looking forMD (or equivalent); with clinical experience in neurology, paediatric neurology or paediatrics preferred7+ years of industry PV experience, with both Clinical Safety and Post-Marketing exposureHands-on, full process signal detection experience, not just oversightRare disease mindset - you understand what these patients and families are counting onA builder: energised by process creation, not process followingCollaborative by nature - this role requires influence, not authorityThe company is lean, growing fast, and backed by strong cash runway into 2028. The Head of PV has 35 years of experience and is actively looking to develop the next generation of safety leadership.