The Company is seeking a Director, Head of PV and REMS Compliance to lead and ensure the quality and compliance of patient safety processes. The successful candidate will be accountable for global PV quality and compliance oversight, US REMS compliance program leadership, and PV quality governance. This role requires a strategic leader with a strong scientific background, approximately 10 years of pharmacovigilance experience, and a minimum of 7 years in a progressive leadership role. The Director will be responsible for driving a culture of innovation, digital maturity, and excellence in quality and compliance, and will serve as a senior subject matter expert, providing strategic guidance to cross-functional partners. Key responsibilities include proactive, risk-based oversight of safety outputs, continuous monitoring of safety deliverables, and ensuring sustained compliance with global GVP regulations. The role also involves leading the design and execution of quality and compliance monitoring programs, driving the use of innovative technology, and fostering a culture of quality excellence and continuous improvement. The ideal candidate will have a Bachelor's degree with a strong scientific background, post-graduate education preferred, and will be adept at building strategic partnerships, influencing without direct authority, and leading high-performing teams. The Director will be expected to communicate a clear vision for global safety reporting and compliance requirements and to apply deep regulatory and risk-based expertise to anticipate and mitigate the impact of global regulatory requirements on pharmacovigilance operations.

Hiring Company

Bristol-Myers Squibb