Director, PV Global Process Lead (GPL)

Functional Area 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.

Position Summary / Objective

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.

Position 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.

• Engage 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.

• Conduct 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.

Disclaimer

The responsibilities outlined above provide a broad overview of the key duties and expectations for this role. Additional responsibilities and tasks may be assigned as required to meet the evolving needs of the organization.

Degree/Experience 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.

Key Competency Requirements

• 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.

Travel Required

Up to 5% travel to support continuous improvement initiatives, process reviews, training and team meetings.

Compensation Overview

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefit Offerings

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support Programs: BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 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.
• Work-life Benefits: Paid Time Off, Unpaid Time Off, Leaves of Absence, etc.

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.

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.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about this here.