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) #J-18808-Ljbffr Scorpion Therapeutics