Head, US Pharmacovigilance Operational Excellence

Job Description Summary

The Head of US Pharmacovigilance Operational Excellence is a leader responsible for driving strategic initiatives, innovation, and process transformation across the pharmacovigilance (PV) function. This role leads project management efforts and builds operational excellence capabilities to optimize efficiency, ensure quality, and maintain regulatory compliance. The role also oversees training, inspection readiness, and continuous improvement, fostering a culture of excellence and high performance. This role will also be leveraging benchmarking, competitive intelligence, business insights, and data-driven analyses to shape and execute strategies that drive competitive advantage and outcomes.

 

Job Description

#LI-Hybrid

Key Responsibilities:

Project Management & Change Leadership

• Lead and oversee a portfolio of high-impact pharmacovigilance (PV)/projects, ensuring timely delivery, stakeholder engagement, and measurable outcomes; spanning compliance, technology, systems implementation, organizational readiness, and process improvement
• Drive change management to support adoption of new tools, systems, and evolving compliance standards utilizing Lean, Six Sigma, and Agile methodologies to enhance quality and efficiency.
• Participate in global and cross-functional projects and meetings to ensure alignment and collaboration.

Operational Excellence, Process Development & Continuous Improvement

• Establish operational governance through the development and oversight of key performance indicators (KPIs)/metrics, leveraging dashboards & tools to monitor effectiveness, review trends monthly, identify and address performance gaps, and ensure accountability and alignment with business objectives to foster a performance-driven culture
• Lead the development, review, and ongoing enhancement of pharmacovigilance (PV) processes by simplifying and streamlining workflows through technology-driven solutions and implementing optimization opportunities
• Coordinate resource planning and budget management to ensure optimal allocation, cost-effectiveness, and support for strategic priorities

Compliance, Training & Inspection Readiness

• Lead investigations, root cause analyses, and CAPA development, identifying trends and systemic gaps, risk assessments, and quality improvement initiatives
• Design and manage a robust training framework that includes onboarding and continuous education to upskill teams, while ensuring compliance through accurate recordkeeping, regular monitoring, and periodic effectiveness assessments
• Drive audit and inspection readiness by managing logistics and execution, including mock audits, SME preparation, and development of inspection materials (e.g., opening presentations)

Strategic Advisory & Facilitation

• Develop and drive strategic roadmaps by identifying gaps and defining actions needed to optimize decision-making and ensure long-term success.
• Serve as a trusted advisor to senior leadership, participate in cross-functional meetings, offering expert guidance on strategy, regulatory compliance, and operational efficiency
• Act as a liaison among PV teams, regulatory authorities, and internal stakeholders to ensure alignment with best practices and regulatory expectations.

Essential Requirements:

• Advanced degree in life sciences, pharmacy, medicine, or related field (PharmD, MD, PhD, or equivalent)
• Minimum 8-10 years of relevant pharmacovigilance experience in the pharmaceutical, biotech, or CRO industry including medicinal, medical device, drug-device combination products or advanced therapies
• At least 3 years of demonstrated leadership in pharmacovigilance, including areas such as strategy, case management, PV compliance, inspection management, process development, and training, preferably in a matrixed or global environment within a multinational pharma company
• Proven expertise in project and program management, including PMO responsibilities
• Excellent organizational, analytical, and strategic planning skills, with strong attention to detail and a proven ability to resolve discrepancies and solve complex problems
• Exceptional interpersonal, communication, and stakeholder engagement skills, with the ability to influence at senior levels and foster a culture of innovation, collaboration, and accountability.
• Strong change management capabilities with the ability to influence and guide cross-functional teams through transformation.
• Strong knowledge of FDA, EMA, and ICH GVP regulations and industry best practices.

Desirable Experience

• Strong knowledge of methodologies such a