Executive Director, Head of PV Operations Oversight
Takeda
August 14, 2026
Remote friendly (Boston, MA)
United States
$238,000 - $374,000 USD yearly
Operations
Objective / Purpose:
- Provide strategic leadership and oversight for global pharmacovigilance (PV) operations, ensuring timely, accurate, compliant collection, processing, evaluation, reporting, and compliance management of safety information across the product lifecycle.
Accountabilities:
- Lead global PV operations: global case processing; ICSR management; medical coding, triage, and quality review; regulatory reporting; market research/patient support programs (MR/PSP); PV review/approval of digital assets and social media programs before launch.
- Establish global PV Operations strategy, governance frameworks, operating model, and operating objectives.
- Ensure operational scalability through forecasting, resource planning, and high-quality, compliant delivery.
- Provide vendor governance/outsourcing oversight: executive sponsorship of PV service providers; vendor oversight frameworks (performance, financial stewardship, quality controls, compliance monitoring); lead governance committees and strategic business reviews; partner with Finance/Procurement on budgets, contracts, SOWs, invoicing.
- Ensure compliance/quality/inspection readiness with global PV regulations and standards (FDA, EMA, PMDA, MHRA, ICH, etc.); partner with Quality Assurance; lead during inspections/audits with remediation/CAPA.
- Drive continuous improvement and digital transformation (automation, AI, analytics, innovative technologies); manage operational performance metrics and dashboards.
- Lead and develop a global team; foster a patient-centric, accountable culture; partner cross-functionally (PSPV, QPPV, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, DQS).
Education & Competencies (Technical/Behavioral):
- Bachelor’s degree in life sciences/healthcare/pharmacy (advanced degree preferred).
- 15+ years in pharma/healthcare; 10+ years progressive PV operations/safety reporting.
- Experience with global case processing/regulatory reporting and leading global teams; managing CROs/vendors/outsourcing.
- Experience with Argus, ArisG, or similar enterprise safety systems.
- Strong knowledge of PV regulations (GVP, FDA/EMA, ICH) and regulated-environment compliance.
- Excellent leadership, communication, stakeholder management, analytical/problem-solving, financial/operational management, and project/program management.
Travel Requirements:
- Up to 15% domestic/international travel.
Benefits/Compensation:
- U.S. base salary range (Boston, MA): $238,000–$374,000; eligibility for incentives and benefits including medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, paid holidays, well-being benefits, sick time (up to 80 hours/year) and vacation (up to 120 hours for new hires).
Application Instructions:
- Apply using the “Apply” button (employment application processing begins; information processed per privacy notice and terms of use).
- Provide strategic leadership and oversight for global pharmacovigilance (PV) operations, ensuring timely, accurate, compliant collection, processing, evaluation, reporting, and compliance management of safety information across the product lifecycle.
Accountabilities:
- Lead global PV operations: global case processing; ICSR management; medical coding, triage, and quality review; regulatory reporting; market research/patient support programs (MR/PSP); PV review/approval of digital assets and social media programs before launch.
- Establish global PV Operations strategy, governance frameworks, operating model, and operating objectives.
- Ensure operational scalability through forecasting, resource planning, and high-quality, compliant delivery.
- Provide vendor governance/outsourcing oversight: executive sponsorship of PV service providers; vendor oversight frameworks (performance, financial stewardship, quality controls, compliance monitoring); lead governance committees and strategic business reviews; partner with Finance/Procurement on budgets, contracts, SOWs, invoicing.
- Ensure compliance/quality/inspection readiness with global PV regulations and standards (FDA, EMA, PMDA, MHRA, ICH, etc.); partner with Quality Assurance; lead during inspections/audits with remediation/CAPA.
- Drive continuous improvement and digital transformation (automation, AI, analytics, innovative technologies); manage operational performance metrics and dashboards.
- Lead and develop a global team; foster a patient-centric, accountable culture; partner cross-functionally (PSPV, QPPV, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, DQS).
Education & Competencies (Technical/Behavioral):
- Bachelor’s degree in life sciences/healthcare/pharmacy (advanced degree preferred).
- 15+ years in pharma/healthcare; 10+ years progressive PV operations/safety reporting.
- Experience with global case processing/regulatory reporting and leading global teams; managing CROs/vendors/outsourcing.
- Experience with Argus, ArisG, or similar enterprise safety systems.
- Strong knowledge of PV regulations (GVP, FDA/EMA, ICH) and regulated-environment compliance.
- Excellent leadership, communication, stakeholder management, analytical/problem-solving, financial/operational management, and project/program management.
Travel Requirements:
- Up to 15% domestic/international travel.
Benefits/Compensation:
- U.S. base salary range (Boston, MA): $238,000–$374,000; eligibility for incentives and benefits including medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, paid holidays, well-being benefits, sick time (up to 80 hours/year) and vacation (up to 120 hours for new hires).
Application Instructions:
- Apply using the “Apply” button (employment application processing begins; information processed per privacy notice and terms of use).