Description
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 shape the future of healthcare and strengthen the foundation of Patient Safety.
Position Summary / Objective
The Director, PV Global Process Lead, will design, optimize, and oversee one or more core pharmacovigilance processes, including ICSR management, signal management, safety aggregate reporting, 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.
Position Responsibilities
1. Lead the design, optimization, and oversight of core PV processes within your assigned L2 pillar, ensuring effectiveness, inspection readiness, and alignment with regulatory requirements, industry best practice, and business priorities.
2. Partner with Global Process Owners (GPOs) to define and deliver process strategies and roadmaps, ensuring cross-functional alignment and visibility of downstream impacts.
3. Serve as the principal subject matter expert for assigned processes, engaging with Local Markets, governance bodies, and stakeholders to maintain consistent, non-siloed process oversight.
4. Lead and actively engage Communities of Practice, fostering knowledge sharing, capability building, and adoption of good practices
5. Drive metric-based demand and capacity planning, using benchmarking, KPIs, and other tools to inform decisions and prioritization.
6. Lead Policy Evaluation and Regulatory Landscape (PEARL) assessments for assigned processes and oversee implementation of resulting changes.
7. Define, monitor, and report on process health metrics (e.g., cycle times, efficiency, productivity) to drive continuous improvement and accountability.
8. Map processes in designated process mapping tools to ensure accuracy, usability, and alignment with procedural documentation.
9. Author and maintain assigned procedural documents and PV System Master File sections; collaborate with Enterprise Learning to assess training impact and ensure operational integration.
10. Partner with Business Capability Enablement (BCE) and Strategy & Operations teams to deliver process improvement initiatives, tools, and technology enhancements.
11. Represent the organization externally through contributions to industry working groups, benchmarking forums, and conferences to influence best practice and policy.
Degree/Experience Requirements
12. Bachelor’s degree or equivalent experience; advanced degree preferred.
13. Extensive PV experience across core PV processes.
14. Proven track record of end-to-end process ownership, including design, mapping (e.g., Adonis), optimization, and governance.
15. Skilled in authoring and maintaining procedural documents.
16. Demonstrated experience in regulatory inspection readiness, participation, and follow-up.
17. Experience leading cross-functional governance, Communities of Practice, and external engagement with industry working groups.
18. Strong background in KPI measurement, benchmarking, and process monitoring.
Key Competency Requirements
19. Strategic process leadership with deep regulatory and technical expertise.
20. Skilled collaborator and influencer across global, matrixed organizations, able to work effectively with GPOs, GPLs, and Local Markets.
21. Strong analytical skills; able to use data to drive prioritization and decision making.
22. Clear, concise communicator with the ability to engage senior stakeholders and diverse audiences.
23. Change leader with a continuous improvement mindset; able to embed innovation and manage complexity.
24. Resilient, adaptable, and culturally aware with a global mindset
Travel Required: Limited travel (up to 5%) to support continuous improvement initiatives, process reviews, training and team meetings.
Compensation Overview:
Madison - Giralda - NJ - US: $217,520 - $263,577
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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. Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.