Job Description:
• Play a pivotal role in commercialization of their first product
• Provide pharmacovigilance leadership and oversight
• Prepare for and lead FDA inspections
• Ensure alignment of safety strategy across departments
• Build and scale pharmacovigilance systems from early-stage to commercial readiness
• Establish and maintain inspection-ready documentation
• Manage safety vendors and ensure compliance
Requirements:
• 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.
Benefits:
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