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, Pharmacovigilance and REMS Compliance
Builds
Global PV and US REMS compliance programs, quality monitoring systems, and governance frameworks
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Required skills
Pharmacovigilance leadership, REMS program management, GVP regulation expertise, FDA compliance, risk-based quality oversight, strategic partnership building, team development, regulatory risk analysis, cross-functional influence, digital/AI tool adoption
Preferred skills
Post-graduate education in science, experience with AI and digital tools for quality programs
Technologies
AI tools, digital quality tools, REMS 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 sponsor of REMS Governance Forum; Develop and mentor high-performing teams; Build strategic partnerships across Patient Safety, R&D Quality, Regulatory Affairs, IT, and Legal; Apply deep regulatory and risk-based expertise to anticipate impact of global regulatory requirements
Seniority
Director, strategic leadership and team management