Global Pharmacovigilance Operations Leader

Brief Description: The Senior Manager, Pharmacovigilance (PV) Operations provides operational leadership and leads execution of global PV operational activities across clinical trial and post‑marketing programs. The role owns and provides support for safety database configuration, regulatory intelligence implementation, vendor performance, and operational readiness to lead global product launches and country expansion, while ensuring compliant, high‑quality, and inspection‑ready PV operations. Essential Functions/Responsibilities Lead and drive execution of global pharmacovigilance operational activities across clinical trial and post‑marketing programs. Drive PV operational readiness for global product launches and new market expansions. Serve as a recognized PV Operations subject matter expert (SME) providing operational guidance in cross‑functional initiatives. Ensure and continuously monitor PV operations for compliance, consistency and inspection readiness. Manage safety reporting activities across the portfolio, including device‑related safety events (e.g., SADEs, malfunctions) and compliance with Medical Device Reporting (MDR) and In Vitro diagnostic Regulation (IVDR) requirements, in compliance with applicable global regulations. Provide functional leadership and direction to vendors, CROs, and cross‑functional partners. Regulatory Intelligence & Country Expansion Monitor, interpret, and apply regulatory intelligence for new and existing markets to identify PV obligations, including ICSR reporting requirements, data retention expectations, and local authority requirements. Translate regulatory requirements into scalable, actionable safety database configuration and operational solutions. Collaborate with Safety Systems Management to implement, test, and validate safety system configuration changes. Lead development and maintenance of country‑specific configurations, including reporting rules and reporting destinations. Liaise with EU/UK QPPV offices to ensure alignment of country expansion activities with global PV system and QPPV requirements (e.g., PSMF alignment, local literature monitoring, local safety contact points). Safety Systems & Database Activities Lead and coordinate safety database (Argus) configuration updates and maintenance activities including expedited reporting rules and reporting destinations for clinical trial and post‑marketing ICSSRs. Lead, coordinate, and perform safety database workflow validation, User Acceptance Testing (UAT), and impact assessments for configuration changes, new study startups, and product launch preparation. Support safety system upgrades and enhancements from an operational perspective. Vendor Oversight & Case Management Provide functional oversight and accountability for outsourced case management and safety reporting vendor activities. Ensure quality, consistency, compliance, and timeliness of end‑to‑end case processing. Monitor metrics, KPIs, and trends to identify quality gaps and operational risks. Proactively manage vendor performance, including issue escalation, mitigation planning, and performance improvement actions. Lead and perform reconciliation activities, ensuring accuracy, completeness, and timely resolution of discrepancies in collaboration with internal teams and vendors, as applicable. Compliance, Quality & Continuous Improvement Lead risk‑proportionate compliance monitoring activities and contribute to cross‑functional quality initiatives. Drive investigations, root cause analyses, and contribute to corrective and preventive action (CAPA) development and effectiveness monitoring. Track trends and metrics, translate findings into actionable improvement plans, and monitor outcomes. Contribute to continuous improvement initiatives and cross‑functional projects to enhance PV operational efficiency and quality. Serve as a key PV Operations SME during audits and inspections, including inspection preparation and response activities. Training & Documentation Create, review, and deliver training for PV operational processes and systems. Provide ongoing functional leadership, oversight and guidance to PV vendors and CROs. Author and/or review SOPs, work instructions, and guidance documents related to PV Operations and Vendor Oversight in collaboration with cross‑functional stakeholders. Ensure PV documentation and training materials remain current and compliant. Required Knowledge, Skills, and Abilities Pharmacovigilance experience, including clinical trial and post‑marketing PV. Demonstrated experience with global safety database configuration and maintenance (Argus). Strong knowledge of global pharmacovigilance regulations (including PMDA, MENA, LATAM, APAC) and ICSR reporting requirements. Experience supporting global product launches and country expansions. Experience with outsourced PV models and vendor oversight. Hands‑on experience with safety systems, E2B reporting, and workflow validation/UAT. Strong analytical skills with the ability to identify trends and translate data into operational actions. Strong written and verbal communication skills. Ability to independently manage complex PV operational activities with minimal supervision in a matrixed, remote environment. Demonstrated experience managing safety reporting activities related to medical device and combination product cases, including the processing of Serious Adverse Device Effects (SADEs), device malfunctions, and compliance with applicable US Medical Device Reporting (MDR) and EU IVDR requirements. Required Education and Licenses Bachelor’s degree in life sciences, pharmacy, nursing, or related scientific discipline required; Advanced degree or healthcare professional qualification (e.g., Pharm.D., RN/BSN/MSN) preferred #J-18808-Ljbffr Jazz Pharmaceuticals