Senior Director, PV Process Lead
About The Position
The Senior Director, Pharmacovigilance (PV) Process Lead is the enterprise process owner and central orchestrator for designated end-to-end PV processes. The role sets process strategy, direction, and accountability, and oversees implementation to ensure processes meet health authority requirements and support organizational priorities. It builds trusted relationships with senior stakeholders across Takeda functions, regions, and cultures, driving alignment, decision-making, accountability, and effective cross-functional governance. The role owns the design, procedural documentation, implementation, management, and oversight of designated E2E PV processes, with scope potentially expanding to additional processes. It develops, authors, maintains, and approves procedural documents, templates, forms, training materials, and toolkits, and provides input to related sub-function documents. The role proactively identifies process risks, trends, and gaps; ensures their escalation, mitigation, and resolution; and serves as the principal contact for related Quality Events, CAPAs, Change Controls, audits, and health authority inspections. The PV Process Lead assesses the impact of changing PV regulatory requirements and oversees the implementation of necessary process updates. It champions technology and AI-enabled capabilities to improve efficiency and operational excellence while maintaining compliant, inspection-ready processes with clear roles and responsibilities. The role also provides backup for other designated processes as needed and performs other duties requested by management.
Requirements
- Bachelor’s degree or international equivalent required; Life Sciences preferred.
- 10+ years of experience in the pharmaceutical industry focused on drug safety and pharmacovigilance.
- Deep PV knowledge and subject matter expertise in designated E2E PV processes.
- Deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines, with extensive understanding of PV processes.
- Comprehensive understanding of the pharmaceutical industry and PV compliance.
- Proven senior leadership experience, including managing matrix teams and fostering enterprise-level cross-functional partnerships.
- Strong strategic and critical thinking, negotiation, and influencing skills across all levels of the business.
- Excellent planning, execution, and communication skills, with a drive to deliver results.
- Ability to collaborate with and influence functional areas, partners, regions, and cultures.
- Healthcare business acumen and a comprehensive understanding of the pharmaceutical industry.
- Strong analytical, judgment, and critical-thinking capabilities, including the ability to understand, synthesize, and communicate complex information.
- Project management skills, including managing time and multiple priorities.
- Ability to inspire, influence, motivate, and drive results at enterprise level.
- Ability to reconcile conflicting views into a cohesive path forward and distill complex issues into clear terms.
- Ability to synthesize diverse stakeholder input to drive innovative solutions and make timely decisions.
- Ability to build strong partnerships and establish role clarity with interfacing functions.
- Ability to work in a complex global ecosystem and maintain an enterprise-level perspective.
- Excellent verbal and written communication skills to persuasively convey ideas and data.
- Demonstrates a diversity and inclusion mindset and models inclusive behavior.
- Ability to navigate change, lead others through change, and challenge the status quo with innovative solutions.
- Ability to identify process improvement opportunities and manage interdependencies across processes.
Nice To Haves
- Life Sciences degree preferred.
Responsibilities
- Own the strategy, direction, design, implementation, management, and oversight of designated end-to-end PV processes.
- Serve as the enterprise process owner and central orchestrator, building stakeholder relationships and driving alignment, decision-making, and accountability.
- Establish cross-functional governance, roles, decision accountability, and forums to support collaboration, transparency, and execution.
- Develop, author, maintain, and approve process procedures, templates, forms, training materials, and toolkits; provide input on related sub-function documents.
- Identify process risks, trends, and gaps, and ensure timely escalation, resolution, and mitigation in line with regulatory expectations.
- Serve as the main point of contact for Quality Events, CAPAs, and Change Controls related to designated processes.
- Represent designated processes during audits and health authority inspections.
- Assess process impacts of changes in PV regulatory requirements and oversee implementation of updates needed for compliance.
- Use technology and AI-enabled capabilities to improve process efficiency and operational excellence while maintaining inspection readiness.
- Provide support and backup for other designated E2E PV processes as needed.
- Perform other duties as requested by management.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
