Executive Director, Head of PV Operations Oversight

Role: Executive Director, Head of Pharmacovigilance Operations Oversight, provides strategic leadership and manages Takeda's global PV operations, ensuring compliant and efficient safety data collection, processing, and reporting across the product lifecycle. Responsibilities include overseeing case intake, medical coding, regulatory submissions, PV review of digital assets, vendor governance, and inspection readiness. Leads a global team focused on operational excellence, digital transformation, and continuous improvement, while managing relationships with CROs and external vendors. Ensures compliance with global regulations (FDA, EMA, ICH) and maintains quality standards, audit readiness, and risk mitigation. Drives innovation through process optimization, automation, and advanced analytics. Collaborates with cross-functional stakeholders including Medical Affairs, Regulatory, Quality, and Clinical teams. Qualifications include a bachelor’s in life sciences or healthcare, with 15+ years in pharma/healthcare and 10+ years leading PV operations in regulated environments. Deep expertise in global PV systems (Argus, ArisG), compliance frameworks, and vendor management is required. Experience managing global teams and leading strategic vendor partnerships is essential. The role involves up to 15% domestic and international travel, with the position based in Boston, MA.