Senior Director, EEA Deputy QPPV

Senior Director, EEA Deputy QPPV

BMS - Bristol-Myers Squibb

Vienna, Austria

Job Description

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.

Key Responsibilities

• 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 others for best results;
• Subject matter expert in EEA and any other relevant legislation with regard to pharmacovigilance (e.g. ICH, CIOMS), as well as BMS Patient Safety related process and systems;
• Utilizes effective decision-making and a problem-solving approach to address safety issues, in a timely manner, while balancing the operation and strategic needs. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates clearly articulated safety issues to the QPPV;
• Ability to work on multiple projects or tasks and utilize effective problem-solving approaches and independently follows up and resolves outstanding issues;
• Successful and creative negotiation of difficult scientific safety issues and think creatively about modifiable variables to optimise the outcome;
• Very good experience in RMP, PSURs/PBRERs, DSURs, US Periodic data presentations and interpretation requirements applied during reviews.