Executive Director, Global Pharmacovigilance Operations, Quality & Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, lead, coach, and mentor the Global Pharmacovigilance Operations, Quality & Compliance team while contributing to the Global DSPV talent strategy.

• Set functional objectives, prioritize operating model initiatives, and define long-term goals that align with Corporate and Global DSPV objectives.

• Ensure that the global Pharmacovigilance (PV) system is scalable, compliant, inspection-ready, and positioned to facilitate portfolio growth, product approvals, commercialization, launches, and regional expansion.

• Oversee global PV operations, encompassing intake, triage, case processing, quality control, regulatory reporting/submission, reconciliation, and supervision of safety information.

• Ensure that PV operational activities adhere to global regulatory standards, Good Pharmacovigilance Practices, and internal policies and procedures.

• Manage PV operational performance, vendor execution, trend analysis, and continuous improvement initiatives.

• Provide operational assistance for programs and PV-related Trial Master File (TMF) activities.

• Maintain PV policies, Standard Operating Procedures (SOPs), procedures, forms, and process governance.

• Take ownership of the oversight and management of the Pharmacovigilance System Master File.

• Establish and uphold the global adverse-event reporting training program, ensuring training compliance.

• Direct the DSPV deviation and Corrective and Preventive Action (CAPA) strategy, including documentation, monitoring, trend analysis, effectiveness checks, KPI development, quality/compliance metrics, and Quality System Management Reporting (QSMR) reporting.

• Supervise Good Pharmacovigilance (GVP) due diligence, audits, inspections, responses, and commitment tracking.

• Manage PV vendor oversight and governance, focusing on performance, quality, escalation, and compliance monitoring.

• Lead the negotiation of Safety Agreements/PVAs, Statements of Work, partner relationships, and ensure contractual compliance.

• Assist partners/vendors with PV due diligence, audits, inspection readiness, and participation in external governance forums.

• Perform additional duties as assigned.

⛳️ Requirements

• A Bachelor's degree, with an advanced degree preferred in a scientific discipline; a healthcare professional degree (PharmD, RPh, RN/BSN, MPH) is preferred.

• At least 15 years of global full life-cycle DSPV experience, including responsibilities in clinical and post-marketing pharmacovigilance.

• Hands-on experience in PV Operations, vendor/alliance management, and GVP-related Quality Management/Compliance within the pharmaceutical or biotechnology sector; experience in rare diseases is a plus.

• Proven track record of leading global teams, encompassing direct leadership, matrix leadership, performance management, and talent development.

• Demonstrated ability to influence senior stakeholders and collaborate effectively across functions, including Clinical Development, Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial, Legal/Contracts, vendors, partners, and senior management.

• Direct experience in preparing for, leading, supporting, and responding to global regulatory authority PV/GVP inspections, including those conducted by the FDA and EMA where applicable.

• Comprehensive knowledge of global safety and PV regulatory requirements, GVP, FDA, EMA, ICH guidance, and relevant international regulations related to clinical development and post-marketing safety.

• Experience in leading and scaling a global PV operations, quality, and compliance function within a dynamic and expanding organization.

• Demonstrated capability to lead in outsourced and vendor-heavy operational models.

• Background in supporting commercialization, product launches, portfolio growth, and regional expansion.

• Familiarity with PV system governance, process ownership, inspection-ready quality systems, and continuous improvement methodologies.

• Working knowledge of industry-standard safety databases, Trial Master File systems (e.g., Veeva Vault eTMF), and other electronic data capture systems.

• MedDRA trained with practical knowledge of MedDRA and WHO Drug dictionaries.

• Willingness to travel, including both national and international travel as required by business needs.

🏝️ Benefits

• Generous vacation time and public holidays recognized by the company.

• Volunteer days.

• Long-term incentive and Employee stock purchase plans or equivalent offerings.

• Employee wellbeing benefits.

• Fitness reimbursement.

• Tuition sponsorship.

• Professional development plans.