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 visitwww.jazzpharmaceuticals.comfor more information. 9-month FTC Remote working ASAP start The Senior Pharmacovigilance Study Operations Lead plays a crucial role in ensuring the effective and compliant collection, safety assessment, processing, and reporting of adverse event (AE) data in line with global regulations and Jazz Pharmaceuticals' procedures. This role may involve performing or supporting accurate data entry, facilitating smooth workflows, and timely reporting of AEs to regulatory authorities. The Sr. case Management Specialist will participate in clinical safety management, manage adverse event workflows, and support policy and SOP development. Additionally, they may contribute to special projects as assigned by Pharmacovigilance Operations (PV Ops) management and may serve in specific case management roles such as Intake & Submissions or Global Case Processing. Primary Responsibilities: Case Processing and Safety Data Management: Maintain high-quality, timely review, coding, data entry, and quality assurance of ICSRs in the Global Safety Database, ensuring adherence to Jazz standards and regulatory requirements. Coordinate with internal stakeholders to align case processing standards with regulatory needs and business objectives, such as risk management, aggregate data analysis, and safety reporting. Vendor and Compliance Oversight: Oversee pharmacovigilance activities conducted by vendors, ensuring consistent, compliant practices. Track KPIs and metrics, manage case quality, and coordinate QC activities for SAE/ICSR entries in the Safety Database. Support vendor case processing through training and monitoring compliance with reporting standards and global safety guidance. Operational Management and Process Improvement: Support the setup, maintenance, and enhancement of adverse event workflows and systems. Identify opportunities to improve processes through internal/external insights, regulatory updates, and best practices in pharmacovigilance. Safety Information and Labeling Support: Assist in preparing and maintaining Reference Safety Information (RSI), labeling documents, and safety sections of regulatory submissions (e.g., DCSI, CCSI, IB). Oversee day-to-day ICSR activities with vendors, ensuring data accuracy, completeness, and regulatory compliance. Act as an expert resource for system configuration, database queries, and system testing to support safety data management needs. Regulatory Reporting and Project Leadership: Lead the preparation of safety-related plans with internal and external partners to ensure consistent, compliant safety reporting across clinical trials. Contribute to safety-related sections of study reports, annual safety updates, and expedited reports for global regulatory submissions. Respond to safety-related queries from regulatory authorities or Ethics Committees, and manage deviation and CAPA activities for case management. Training, Mentorship, and Team Collaboration: Provide case processing training and guidance for vendors and cross-functional teams. Mentor CM team members and support team operations and workflow coordination as needed. Participate in audits and inspections, maintaining an inspection-ready operational state. Cross-Functional and Inspection-Readiness Collaboration: Serve as a PV liaison to clinical teams, supporting Safety Management Plans, SAE reconciliation, protocol development, and clinical study reports. Collaborate with GRADS AM, GRADS Compliance, R&D Quality, and Clinical teams to monitor performance, resolve bottlenecks, and reduce regulatory risk in adverse event management. Essential Functions/Responsibilities Act as the primary PV liaison to clinical teams, supporting Safety Management Plans, protocol development, study startup, clinical study reports, informed consent, and the review of study documents. Oversee SAE reconciliation and study closure activities. Follow company templates and GxP guidelines for documentation and communications, ensuring accuracy and compliance. Ensure adherence to corporate and departmental policies, SOPs, and timely completion of all assigned training. Support Case Management Operations and Teams with various tasks as needed. Contribute to developing adverse event case management workflows and training materials when introducing new or updated processes. Assist in coordinating department workflows and participate in special projects as directed by CM department management. Serve as an individual contributor or project manager for functional projects or workflows. Mentor other CM team members, including service providers, to build team capability. Participate in inspections and audits as required, ensuring an inspection-ready operational state. Take responsibility for personal development, staying updated on pharmacovigilance practices, regulations, and guidelines. Collaborate with GRADS AM, GRADS Compliance, PV Ops, R&D Quality, and Clinical teams to assess performance, identify bottlenecks, reduce regulatory risks, and improve adverse event management processes. Act as team lead in the absence of the manager, assuming key responsibilities as needed. Required Knowledge, Skills, and Abilities Pharmaceutical drug safety/pharmacovigilance experience. Experience with quality management systems (e.g., document management, learning management, change control). Comprehensive knowledge of FDA and international regulations related to AE and ICSR requirements, with the ability to interpret and apply these regulations. Proven ability to collect, analyze, disseminate, and report safety information in compliance with global regulations. Proficiency in standard desktop software (Word, Excel, Outlook). Proficient with safety database applications. Experience using MedDRA and MedDRA coding. Strong understanding of medical terminology and ability to summarize medical information. Excellent oral and written communication skills. Highly organized with strong attention to detail. Demonstrated accountability for results, problem-solving, and decision-making abilities. Strong time management, prioritization, and planning skills, with the ability to work under strict timelines. Quality-oriented mindset with attention to detail. Ability to adhere to established processes and adapt to new priorities, demonstrating a continuous improvement mindset. Ability to work collaboratively within a team in a dynamic, fast-paced environment. Flexibility to work outside normal hours or on-call as needed. Required/Preferred Education and Licenses BS/BA degree in health-related or biological science-related field required LI-SM1 LI-remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:https://careers.jazzpharma.com/benefits.html.
