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, PV Operations provides strategic and operational leadership for global Pharmacovigilance (PV) Operations. This role drives process optimization, operational governance, vendor oversight, and cross‑functional alignment to ensure compliant, efficient, and high‑quality safety operations. The Senior Manager leads continuous improvement efforts, oversees end‑to‑end post‑marketing safety processes (including ICSR case processing), partners closely with internal and external stakeholders, and ensures inspection readiness across the PV function.

Essential Functions/Responsibilities

• Manage PV Operations team deliverables with high quality, compliance and strong attention to detail

• Lead strategic workstreams that enhance operational quality, efficiency, and compliance.

• Drive process modernization, system enhancements, and operational harmonization across functions.

• Identify opportunities for automation, simplification, and scalability in PV processes and systems.

• Align PV Operations initiatives with organizational priorities and quality expectations.

• Lead evaluation, redesign, and standardization of end‑to‑end PV processes.

• Develop, maintain and optimize procedural documents and workflows.

• Oversee and facilitate ICSR workflow to ensure case processing to internal and regulatory timelines, including engagement of cross-functional stakeholders for timely completion of medical review and/or collection of complete safety information

• Design, monitor, and report KPIs, dashboards, and performance metrics.

• Promote continuous improvement, efficiency, innovation, and operational consistency.

• Ensure global compliance with case processing submission, and safety reporting requirements.

• Oversee quality initiatives, CAPA development, implementation, and effectiveness monitoring.

• Partner with Quality Assurance and Compliance to ensure alignment with quality systems, SOPs and regulatory expectations.

• Oversee strategic vendor partnerships supporting global case processing and reporting, ensuring strong KPIs, SLAs, and risk‑based oversight.

• Collaborate with Global Risk Management, Safety Systems, Compliance, Clinical Operations, and Regulatory Affairs to ensure operational alignment and data integrity.

• Represent PV Operations in cross‑functional projects, system enhancements, and governance forums.

•  Ensure Global clinical trials and/or post-marketed case reporting process is efficient and compliant with reporting requirements detailed in Jazz procedures, safety management plans, PV agreements, local and global regulations

• Contribute to safety database upgrades and configuration changes; perform user acceptance testing

• Provide input and guidance to submissions and case processing vendor teams

• Facilitate training and develop training materials for vendor training

• Serve as SME in audits and inspections

• May be responsible for operational tasks related to maintaining the pharmacovigilance documentation required for the electronic Trial Master File including quality review, organization, maintenance, and storage following study procedures

• Support adverse event reporting or other shared PV Operations mailbox management and monitoring, including triage and archiving of all email

• Support the timely and a