layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Director, EEA Deputy QPPV (m/f/d) at Bristol Myers Squibb

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.

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
Occasional travel may be required in this position, including travel to BMS sites, BMS Headquarters, Health Authorities and to attend professional meetings and seminars.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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R1605639 : Senior Director, EEA Deputy QPPV (m/f/d)

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

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