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 programs.
Role type
Director, Head of PV and REMS Compliance
Builds
Global PV and REMS compliance programs, quality monitoring systems, and governance frameworks
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Required skills
Pharmacovigilance expertise, REMS program management, Quality governance, Risk-based monitoring, Strategic leadership, Cross-functional partnership, Team development, Regulatory interpretation, AI and digital tool adoption, Stakeholder influence
Preferred skills
Post-graduate education in science, Experience with enterprise AI tools, Innovation in compliance workflows
Technologies
Enterprise AI tools, Digital compliance platforms
Responsibilities
Oversee design and execution of quality and compliance monitoring programs for safety outputs; Lead US REMS compliance program including inspection readiness and audit oversight; Act as Business Lead for Safety Quality Management and REMS Governance Forums; Provide strategic guidance to Patient Safety leadership and cross-functional partners; Develop and mentor high-performing teams; Leverage AI and digital tools to drive automation and efficiency in quality programs.
Seniority
Director, strategic leadership & team management
