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At Jazz Pharmaceuticals, a globally recognized biopharma leader, our mission revolves around advancing healthcare to improve the lives of patients and their families. We specialize in creating transformative medications for individuals battling serious diseases, particularly where treatment options are scarce or non-existent. Our diverse portfolio boasts leading therapies for sleep disorders and epilepsy, along with an expanding range of innovative cancer treatments. With a strong commitment to patients and a science-based ethos, our pioneering research and development initiatives drive forward our extensive pipeline in oncology and neuroscience. Headquartered in Dublin, Ireland, we operate research and development laboratories, manufacturing sites, and a dedicated workforce across various countries, all focused on serving patients around the world. Discover more about us on our website.

Duration: 9-month Fixed-Term Contract

Work Arrangement: Remote

Start Date: Immediate

The Senior Pharmacovigilance Study Operations Lead is instrumental in overseeing the thorough and compliant collection, evaluation, processing, and reporting of adverse event (AE) data according to global standards and Jazz Pharmaceuticals’ operational procedures. This position may entail executing or assisting with precise data entry tasks, facilitating seamless workflow, and ensuring prompt AE reporting to regulatory authorities. The Sr. Case Management Specialist will engage in clinical safety management, handle adverse event workflows, and contribute to the development of policies and Standard Operating Procedures (SOPs). Additionally, there may be opportunities to support special projects as designated by the Pharmacovigilance Operations management team, as well as to actively participate in specific case management functions such as Intake & Submissions or Global Case Processing.

Key Responsibilities:

Case Processing and Safety Data Management:

• Ensure high-quality, timely review, coding, data entry, and quality assurance of Individual Case Safety Reports (ICSRs) in the Global Safety Database, adhering to Jazz standards and regulatory mandates.
• Collaborate with internal stakeholders to align case processing procedures with regulatory requirements and business objectives, including risk management and aggregate data analysis.

Vendor and Compliance Oversight:

• Manage pharmacovigilance activities performed by third-party vendors, ensuring consistent and compliant practices.
• Track key performance indicators, manage case quality, and coordinate quality control processes for Serious Adverse Events and ICSR entries in the Safety Database.
• Provide training and oversee compliance with reporting standards and global safety guidelines for vendor case processing.

Operational Management and Process Enhancement:

• Assist in establishing, maintaining, and refining adverse event workflows and systems.
• Identify and implement process improvement opportunities based on industry insights, regulatory updates, and best practices in pharmacovigilance.

Safety Information and Labeling Support:

• Help prepare and maintain Reference Safety Information (RSI), labeling documents, and safety sections of regulatory submissions (e.g., DCSI, CCSI, IB).
• Supervise daily ICSR activities with vendors, ensuring data accuracy, completeness, and regulatory compliance.
• Act as a knowledgeable resource for system configuration, database queries, and system testing to facilitate safety data management needs.

Regulatory Reporting and Project Leadership:

• Lead the creation of safety-related plans with both internal and external partners to maintain consistent and compliant safety reporting throughout clinical trials.
• Contribute to safety-oriented sections of study reports, annual safety updates, and expedited reports for global regulatory submissions.
• Address safety-related inquiries from regulatory authorities or Ethics Committees, managing deviations and CAPA activities in case management.

Training, Mentorship, and Team Collaboration:

• Deliver case processing training and mentorship for vendors and cross-functional teams.
• Guide and support CM team members in day-to-day operations and workflow coordination as necessary.
• Engage in audits and inspections, ensuring operational readiness for inspections.

Cross-Functional and Inspection-Readiness Collaboration:

• Act as the Pharmacovigilance liaison for clinical teams, assisting in the development of Safety Management Plans, SAE reconciliation, and protocol development.
• Collaborate with GRADS AM, GRADS Compliance, R&D Quality, and Clinical teams to enhance performance, resolve issues, and mitigate regulatory risks in adverse event management.

Essential Functions/Responsibilities

• Serve as the primary Pharmacovigilance liaison to clinical teams, supporting Safety Management Plans, protocol development, study startup, and clinical study reports, while overseeing SAE reconciliation and study closure activities.
• Follow company templates and Good X Practice (GxP) guidelines for documentation and communications, ensuring accuracy and compliance.
• Adhere to corporate and departmental policies, SOPs, and timely completion of all assigned training.
• Assist Case Management Operations and teams with various support tasks as needed.
• Contribute to the development of adverse event case management workflows and training materials for new or updated procedures.
• Help coordinate department workflows and participate in special projects as assigned by the Case Management department’s leadership.
• Serve as an individual contributor or project manager for functional projects or workflows.
• Mentor CM team members, including service providers, to enhance team capabilities.
• Participate in inspections and audits as required, ensuring readiness for regulatory scrutiny.
• Commit to personal development and keep abreast of pharmacovigilance practices, regulations, and guidelines.
• Collaborate with GRADS AM, GRADS Compliance, PV Ops, R&D Quality, and Clinical teams to evaluate performance, identify bottlenecks, mitigate regulatory risks, and refine adverse event management processes.
• Assume a leadership role in the absence of the manager, taking on key responsibilities as required.

Required Knowledge, Skills, and Abilities:

• Demonstrated experience in pharmaceutical drug safety and pharmacovigilance.
• Familiarity with quality management systems (e.g., document management, learning management, change control).
• In-depth understanding of FDA and international regulations concerning AE and ICSR requirements, with the ability to interpret and apply these standards effectively.
• Proven expertise in collecting, analyzing, disseminating, and reporting safety information in compliance with global regulations.
• Proficient in standard desktop software including Word, Excel, and Outlook.
• Working knowledge of safety database applications.
• Experience utilizing MedDRA and MedDRA coding.
• Strong grasp of medical terminology and the ability to summarize medical information effectively.
• Exceptional oral and written communication skills.
• Detail-oriented and highly organized.
• Accountability for results, with robust problem-solving and decision-making skills.
• Strong time management, prioritization, and planning abilities, capable of thriving under strict deadlines.
• Quality-focused mindset with a commitment to detail.
• Capacity to comply with established processes while adapting to evolving priorities, reflecting a continuous improvement approach.
• A collaborative spirit enabling effective teamwork in a dynamic, fast-paced environment.
• Availability to work outside standard hours or be on-call when necessary.

Required/Preferred Education and Licenses:

• A BS/BA degree in a health-related or biological science field is required.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. We welcome applications from all qualified individuals, without discrimination based on race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Successful applicants will have access to a comprehensive benefits package, which includes medical, dental, and vision insurance, retirement savings plans, and flexible paid vacation options. For additional details regarding our benefits offerings, please click here: .