Senior Director – Pharmacovigilance, PV Operations

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November 15

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Implaion Recruiting

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Recruitment • Energy • Construction

Implaion Recruiting is a recruitment agency that prioritizes the human touch in the hiring process. Founded with the belief that great connections are built on understanding and trust rather than just data, Implaion aims to reimagine recruitment by fostering meaningful relationships between talent and opportunity. They specialize in various sectors, including Energy, Construction, and Life Sciences, emphasizing a people-first approach.

0 - 1 employees

🎯 Recruiter

⚡ Energy

📋 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.