Senior Director, EEA Deputy QPPV (m/f/d)

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

In the absence of the QPPV, the Deputy QPPV assumes the responsibilities of the QPPV and, as delegated, performs applicable QPPV activities to ensure continuity of oversight and compliance within the pharmacovigilance system.

The development and maintenance of the safety profile for assigned products; review and approval of PSURs/PBRERs, EU RMPs, PASS and other relevant documents; provision of advice on the management of safety issues; and support for responses to requests and questions from regulatory authorities. Reviews and provides scientific input to PASS and PAES protocols, amendments, final study reports, and related publications (including abstracts and manuscripts) to ensure alignment with study objectives and regulatory expectations. The Deputy QPPV also reviews and provides scientific input to justification documents, variation and renewal submissions, SmPCs, DHPCs, Investigator Letters, response documents, core additional educational materials, health hazard evaluations, and other relevant safety-related documents. Ensures complete, accurate, and timely responses to requests from competent authorities in Member States and from the EMA for information necessary to support the benefit-risk evaluation of medicinal products. Contributes to the oversight and control of the pharmacovigilance system, including compliance with applicable processes and system requirements, and supports internal and external audits and regulatory inspections relating to the scientific activities of the QPPV Office. Communicating product safety information, maintaining awareness of evolving safety profiles across BMS products, and supporting the development and maintenance of key procedural documents, including SOPs and work instructions that define QPPV responsibilities and accountabilities. Participation in PRAC activities and Scientific Advice procedures and, as delegated, represents the QPPV in Medical Review Group meetings, Safety Management Team meetings, and other relevant governance forums addressing signal assessment, risk management strategies, aggregate analyses, epidemiology studies, RSI/CSI topics, signal detection, and aggregate reporting approaches. Works closely with key stakeholders across the organisation, including Quality, EEA Qualified Person (QP) Batch Release, Regulatory Affairs, Clinical Development, and Medical Affairs. The Deputy QPPV may also chair or co-chair the QPPV Safety Forum to facilitate scientific exchange and discussion of benefit-risk updates across products. Qualifications & Experience MD (or international equivalent) or PharmD/PhD with considerable industry experience in Pharmacovigilance At least 10 years in the Pharmaceutical Industry, usually with at least 5 years’ experience working in Pharmacovigilance in a local and regional role and has in addition experience in Regulatory Science and Regulatory Supervisory Agency inspections within EEA A strong background in Pharmacovigilance and excellent knowledge of global and EEA Pharmacovigilance regulatory obligations Demonstrated strong, effective organizational, facilitation, interpersonal and communicating skills with multidisciplinary teams locally, regional and within Patient Safety to achieved desired outcomes Positively contributes to the shaping of pharmacovigilance within the QPPV Office Ability to communicate effectively and efficiently with co-workes and