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 activities 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 re‑imagining procedural documentation and driving the optimal design, implementation, oversight, and continuous improvement of PV processes.

The Director, PV Global Process Lead (GPL) will design, optimize, and oversee one or more core PV processes, with particular emphasis on Safety Aggregate Reports (SAR) as a core end‑to‑end accountability for regulated safety reporting and communication. The role operates within the PV process landscape across ICSR management, signal management, risk management, and the PV System Master File, partnering with Global Process Owners to define and deliver strategies and roadmaps that align with business priorities, regulatory requirements, and inspection readiness.

• Lead the design, optimisation, and oversight of the Safety Aggregate Reporting (SAR) process as the primary assigned process, 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 prioritisation.
• Lead 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.

• 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), optimisation, 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…