Senior Director, PV Process Lead

Responsibilities

• Serves as the enterprise process owner and central orchestrator for E2E PV processes, building and sustaining trusted relationships with senior cross-functional stakeholders, driving alignment, decision-making, and accountability across the organization.
• Drives cross-functional governance and operational excellence by defining roles, decision accountability, and forums that enable collaboration, transparency, and effective execution.
• Owns the design, procedural documentation, implementation, management, and oversight of designated E2E PV processes, with scope expanding to other E2E processes as needed.
• Develops, authors, maintains, and approves procedural documents, associated templates/forms, training materials, and other toolkits for designated E2E PV processes.
• Provides input to associated procedural documents owned by sub-functions in relation to designated E2E PV processes.
• Provides E2E PV oversight for designated processes by proactively identifying risks, trends, and gaps, and ensuring timely escalation, resolution, and mitigation in line with regulatory expectations.
• Serves as the main point of contact for Quality Events, CAPAs, and Change Controls related to the designated processes, and represents those E2E processes during audits and health authority inspections.
• Contributes to process impact assessments in response to changes in PV regulatory requirements identified through regulatory intelligence activities and oversees implementation of necessary updates.
• Champions technology and AI-enabled capabilities to drive continuous process improvement, operational excellence, and efficiency by streamlining E2E processes and maintaining inspection readiness.
• Provides support and back-up for other designated E2E PV processes as needed to ensure continuity, quality, and timely execution.

Qualifications

• Deep PV knowledge and subject matter expertise on designated E2E PV processes.
• Deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines with extensive understanding of pharmacovigilance processes.
• Comprehensive understanding of the pharmaceutical industry and PV compliance.
• Good analytical/judgement and critical thinking capabilities to understand, analyze, synthesize, and communicate.
• Project management skills, including ability to manage time and multiple priorities.
• Enterprise-level leadership with the ability to inspire, influence, motivate, and drive results.
• Demonstrated ability to work across functions, regions, and cultures, and capable of reconciling conflicting views into a cohesive path forward.
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company.
• Ability to distill complex issues and ideas down to simple comprehensible terms.
• Cross-functional collaboration: able to synthesize diverse inputs from multiple constituents and stakeholders to drive innovative solutions.
• Accountability for decision-making for the designated function.
• Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution.
• Ability to build strong partnerships and drive role clarity with other interfacing functions.
• Forward thinking in exploring and leveraging technology and AI-enabled capabilities to drive continuous process improvement, efficiency, and operational excellence.
• Ability to work in a global ecosystem (internal and external) with a high degree of complexity.
• Deep expertise in the pharma industry and PV required.
• Ability to see and understand broader, enterprise-level perspective.
• Excellent communicator, able to persuasively and effectively convey both ideas and data, verbally and in writing.
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
• Is designated as point of contact for audits and inspections pertaining to designated E2E PV processes.
• Is accountable for designing and implementing vision and strategy for designated scope.
• Effectively navigates the changing external and internal environment and leads others through change by creating an inspiring and engaging workplace.
• Stay informed about novel tools and processes, and be comfortable challenging the status quo to bring forward innovative solutions.
• Recognize the opportunity to improve the process to achieve business benefit and identify and manage interdependence across processes.
• Bachelor's degree or international equivalent required; Life Sciences preferred.
• 10+ years' experience in the pharmaceutical industry with a focus on drug safety and pharmacovigilance.
• Proven experience in a senior leadership capacity, managing matrix teams, and fostering strong partnerships and collaborations with cross-functional stakeholders at enterprise level.
• 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 and effectively influence various functional areas, partners, regions, and cultures.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.