Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description
Our client, a fast growing biopharma organization focused on rare autoimmune disorders, is seeking an experienced PV operations professional. This Sr. Director will play a pivotal role in commercialization of their first product. • Extensive pharmacovigilance leadership experience in small-molecule therapeutics, ideally in autoimmune or immunology indications • Direct, hands-on experience preparing for and leading FDA pharmacovigilance inspections (pre-approval inspections in particular) • Demonstrated ability to sit opposite FDA investigators and defend safety systems, processes, and decisions with clarity and confidence • Deep expertise in case processing operations, including oversight of vendors, safety databases, workflow design, quality control, and compliance metrics • Prior responsibility for building or scaling PV systems from early-stage to commercial readiness, including SOP development and governance • Strong understanding of safety aggregate reporting (DSURs, PADERs, periodic benefit-risk evaluations) and how these are audited during inspections • Proven track record establishing inspection-ready documentation, end-to-end safety process maps, and evidence packages for regulators • Experience interacting cross-functionally with clinical development, regulatory affairs, quality, and medical affairs to ensure alignment of safety strategy • Knowledge of NDA requirements for safety sections (Module 2.7.4 and Module 5 safety data organization) and how FDA interrogates these materials • Ability to manage and oversee safety vendors, ensuring compliance, audit findings resolution, and operational readiness • Familiarity with signal detection methodologies and benefit-risk assessments relevant to NDA submissions • Experience training teams for mock inspections and serving as a primary point of contact during actual inspections • Strong operational mindset with the ability to implement scalable PV infrastructure for a company preparing its first commercial launch Company Description Apply tot his job