Executive Director, Head of PV Operations Oversight

3316 Takeda Development Center Americas•Boston, MA

6d•Onsite

About The Position

The Executive Director, Head of Pharmacovigilance Operations Oversight provides strategic leadership and oversight for Takeda's global pharmacovigilance operations, ensuring the effective collection, processing, evaluation, reporting, and compliance management of safety information across the product lifecycle. This role is accountable for the operational performance of global case processing, Individual Case Safety Report (ICSR) management, regulatory reporting, tracking of market research / patient support programs (MR / PSP), performing PV review and approval of digital assets and social media programs before launch, and oversight of pharmacovigilance service providers. The position serves as the primary business leader for PV operational strategy, vendor governance, inspection readiness, and continuous process improvement, ensuring delivery of high-quality, compliant, and efficient pharmacovigilance operations that support patient safety and meet global regulatory requirements. The Executive Director leads a global team responsible for PV operational execution while driving innovation, digital transformation, and operational excellence across Takeda's pharmacovigilance ecosystem.

Requirements

Bachelor’s degree in life sciences, healthcare, pharmacy, or related discipline.
Minimum 15 years of experience in the pharmaceutical or healthcare industry
Minimum 10 years of progressive experience in PV operations and safety reporting.
Demonstrate the ability to work across geographies.
Significant experience overseeing global case processing and regulatory reporting activities and leading global teams within a regulated environment.
Demonstrated experience managing global CROs, strategic vendors, and outsourcing partnerships.
Experience with Argus, ArisG, or other enterprise safety systems and associated technologies.
Deep expertise in global pharmacovigilance operations, case management, and reporting requirements.
Strong understanding of global PV regulations, GVP, FDA, EMA, ICH, and international compliance frameworks.
Exceptional leadership, communication, and stakeholder management skills.
Strong vendor governance and strategic partnership management capabilities.
Demonstrated ability to influence senior leaders and drive organizational change.
Excellent analytical, problem-solving, and decision-making abilities.
Strong financial and operational management acumen.
Proven ability to lead in complex, matrixed, global organizations.
Strong project and program management skills.
Commitment to quality, compliance, and patient safety.
Ability to prioritize competing demands and operate effectively in a fast-paced environment.

Nice To Haves

Advanced degree preferred.

Responsibilities

Provide strategic leadership and oversight of Takeda's global pharmacovigilance operations, ensuring the timely, accurate, and compliant collection, assessment, processing, review, and reporting of safety information across the product lifecycle.
Establish and execute the global PV Operations strategy, governance frameworks, organizational objectives, and operating model to support Takeda's evolving safety portfolio and business priorities.
Oversee pharmacovigilance activities related to case intake, case processing, medical coding, triage, quality review, Individual Case Safety Reports (ICSRs), regulatory reporting, market research programs, patient support programs, and Takeda-sponsored digital assets and social media initiatives.
Ensure appropriate forecasting, resource planning, and operational scalability to support global business needs while maintaining high standards of quality, compliance, and patient safety.
Serve as the executive sponsor for pharmacovigilance service providers, strategic vendors, and outsourcing partnerships, ensuring effective governance, operational delivery, quality performance, and regulatory compliance.
Establish and maintain comprehensive vendor oversight frameworks, including governance structures, performance management, financial stewardship, quality controls, and compliance monitoring.
Lead Joint Operating Committees, Executive Governance Committees, and strategic business reviews to drive accountability, continuous improvement, and long-term partnership success.
Partner with Finance and Procurement to oversee budgets, contracts, statements of work, invoicing, and vendor investment strategies.
Ensure global PV operational activities remain compliant with applicable regulations, guidance, and industry standards, including FDA, EMA, PMDA, MHRA, ICH, and other global health authority requirements.
Partner with Quality Assurance to maintain effective quality systems, vendor oversight procedures, audit programs, quality agreements, and inspection readiness activities.
Provide executive leadership during regulatory inspections, partner audits, and internal assessments, ensuring effective remediation, CAPA implementation, and sustainable compliance improvements.
Maintain robust monitoring programs, operational controls, performance metrics, SOPs, policies, and standards that support ongoing compliance, quality, and operational effectiveness.
Drive continuous improvement, operational excellence, and digital transformation initiatives across the global pharmacovigilance ecosystem.
Identify and implement opportunities to enhance efficiency, quality, scalability, and compliance through process optimization, automation, artificial intelligence, advanced analytics, and innovative technologies.
Lead strategic transformation programs, including operating model evolution, process harmonization, technology implementations, and enterprise-wide optimization initiatives.
Establish and monitor operational performance indicators, dashboards, and business metrics that enable data-driven decision-making and continuous improvement.
Build, lead, and develop a high-performing global organization through talent development, coaching, succession planning, and leadership excellence.
Foster a culture of accountability, inclusion, engagement, innovation, continuous learning, and patient-centricity across the PV Operations organization.
Collaborate closely with PSPV leadership, QPPV, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, DQS, and other cross-functional stakeholders to align operational strategies with enterprise objectives.
Influence senior leaders and external partners to advance strategic priorities, strengthen organizational effectiveness, and deliver sustainable business outcomes.