Director, PV Global Process Lead (GPL)
About The Position
The Patient Safety organization is dedicated to safeguarding the safety of our medicines through comprehensive pharmacovigilance and pharmaco-epidemiology activities. These include single case and aggregate safety monitoring, safety reporting, contributions to benefit-risk assessments, risk management planning and execution, fulfilling specific post-marketing commitments, and ensuring compliance with global regulatory requirements. Within Patient Safety, the Safety Quality Management (SQM) organization and its PV Process Excellence subfunction champion innovation and excellence by reimagining procedural documentation and driving the optimal design, implementation, oversight, and continuous improvement of PV processes. Through smart integration and cross-functional collaboration, they strengthen the foundation of Patient Safety. The Director, PV Global Process Lead, will design, optimize, and oversee one or more core PV processes. This role places particular emphasis on Safety Aggregate Reports (SAR) as a core end-to-end accountability for regulated safety reporting and communication. More broadly, the role operates within the PV process landscape, working across ICSR management, signal management, risk management, and the PV System Master File. Partnering with Global Process Owners, the PV GPL will define and deliver strategies and roadmaps that align with business priorities, regulatory requirements, and inspection readiness. By leading Communities of Practice and driving cross-functional collaboration, the PV GPL will embed best practices, foster continuous improvement, and reinforce BMS’s position as an industry leader in Patient Safety.
Requirements
- Bachelor’s degree or equivalent experience; advanced degree preferred.
- Extensive PV experience with deep expertise in Safety Aggregate Reporting and strong working knowledge of other core PV processes.
- Proven track record of end-to-end process ownership, including design, mapping (e.g., Adonis), optimization, and governance.
- Skilled in authoring and maintaining procedural documents.
- Experience working with global regulatory requirements governing safety aggregate reporting, with an understanding of its interfaces across core PV processes.
- Demonstrated experience in regulatory inspection readiness, participation, and follow-up.
- Experience leading cross-functional governance, Communities of Practice, and external engagement with industry working groups.
- Strong background in KPI measurement, benchmarking, and process monitoring.
- Strategic process leadership with deep regulatory and technical expertise.
- Skilled collaborator and influencer across global, matrixed organizations, able to work effectively with GPOs, GPLs, and Local Markets.
- Strong analytical skills; able to use data to drive prioritization and decision making.
- Clear, concise communicator with the ability to engage senior stakeholders and diverse audiences.
- Change leader with a continuous improvement mindset; able to embed innovation and manage complexity.
- Resilient, adaptable, and culturally aware with a global mindset
Responsibilities
- Lead the design, optimisation, and oversight of the Safety Aggregate Reporting (SAR) process as the primary assigned process within the PV framework, ensuring effectiveness, inspection readiness, and alignment with regulatory requirements, industry best practice, and business priorities.
- Partner with Global Process Owners (GPOs) to define and deliver process strategies and roadmaps, ensuring cross-functional alignment and visibility of downstream impacts.
- Serve as the principal subject matter expert for SAR and related process interfaces, engaging with Local Markets, governance bodies, and stakeholders to maintain consistent, non-siloed process oversight.
- Lead and actively engage Communities of Practice, fostering knowledge sharing, capability building, and adoption of good practices.
- Drive metric-based demand and capacity planning, using benchmarking, KPIs, and other tools to inform decisions and prioritization.
- Lead Policy Evaluation and Regulatory Landscape (PEARL) assessments for assigned processes and oversee implementation of resulting changes.
- Define, monitor, and report on process health metrics (e.g., cycle times, efficiency, productivity) to drive continuous improvement and accountability.
- Map processes in designated process mapping tools to ensure accuracy, usability, and alignment with procedural documentation.
- Author and maintain assigned procedural documents and PV System Master File sections; collaborate with Enterprise Learning to assess training impact and ensure operational integration.
- Partner with Business Capability Enablement (BCE) and Strategy & Operations teams to deliver process improvement initiatives, tools, and technology enhancements.
- Represent the organization externally through contributions to industry working groups, benchmarking forums, and conferences to influence best practice and policy.
Benefits
- Medical, pharmacy, dental, and vision care.
- BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Flexible time off (unlimited, with manager approval, 11 paid national holidays)
- 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
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What This Job Offers
Job Type
Full-time
Career Level
Director
