Director, Head of PV and REMS Compliance
Core
Leading Patient Safety quality and compliance on all key processes through proactive, risk-based oversight and continuous monitoring of safety outputs, ensuring sustained compliance with global GVP regulations and FDA requirements for REMS.
Role type
Director, Head of PV and REMS Compliance
Builds
Safety deliverables, signal management, aggregate reports, regulatory submissions, and validated compliance workflows.
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Required skills
Pharmacovigilance expertise, GVP regulations knowledge, FDA REMS compliance, risk-based monitoring, quality governance, strategic leadership, cross-functional partnership, team development, regulatory risk analysis, digital/AI tool adoption.
Preferred skills
Post-graduate education in science, experience with enterprise AI and digital tools, ability to drive innovation in quality systems.
Technologies
Enterprise AI tools, digital compliance platforms, validated compliance tools.
Responsibilities
Oversee design and execution of quality and compliance monitoring programs for safety outputs; lead US REMS compliance program and audit readiness; act as Business Lead for Safety Quality Management Forum and REMS Governance Forum; provide strategic guidance to Patient Safety leadership; develop and mentor high-performing teams; build strategic partnerships across R&D, Regulatory Affairs, IT, and Legal.
Seniority
Director, strategic leadership & mentorship