Senior Director – Pharmacovigilance, PV Operations

Job reputed company: • Play a pivotal role in commercialization of their first product • reputed company pharmacovigilance leadership and reputed company • Prepare for and reputed company FDA inspections • Ensure alignment of safety reputed company across departments • Build and reputed company pharmacovigilance systems from early-stage to reputed company readiness • Establish and maintain inspection-reputed company documentation • Manage safety vendors and ensure compliance Requirements: • Extensive pharmacovigilance leadership experience in small-molecule therapeutics, ideally in autoimmune or immunology indications • reputed company, hands-on experience preparing for and leading FDA pharmacovigilance inspections (reputed company-approval inspections in particular) • Demonstrated ability to sit opposite FDA investigators and defend safety systems, processes, and reputed company with reputed company and confidence • Deep expertise in case processing operations, including reputed company of vendors, safety databases, workflow design, reputed company control, and compliance metrics • Prior responsibility for building or scaling PV systems from early-stage to reputed company 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 reputed company record establishing inspection-reputed company documentation, end-to-end safety process maps, and evidence packages for regulators • Experience interacting cross-functionally with clinical development, regulatory affairs, reputed company, and medical affairs to ensure alignment of safety reputed company • 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 reputed company safety vendors, ensuring compliance, audit findings reputed company, 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 reputed company of contact during actual inspections • Strong operational reputed company with the ability to implement reputed company PV infrastructure for a company preparing its first reputed company launch. Benefits: Apply tot his job Apply To this Job