Senior Manager, Pharmacovigilance Operations

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

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 ICSRs.
• 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