Executive Director, Head of PV Operations Oversight

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)
• Vacation (up to 120 hours for new hires)