Reference #: R009678 If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.

The Case Management Specialist (CMS) is responsible for participating in, and enabling the timely and accurate collection, safety review, processing, and reporting, of adverse event data in compliance with applicable global regulations and Jazz Pharmaceuticals standard operating procedures and guidelines. The CMS may perform or enable Jazz PV Service Provider to perform accurate computer data entry of identified adverse event information and ensure the uniform and timely processing and reporting of adverse events to global regulatory authorities. The CMS will be heavily involved in clinical safety management activities and will serve as the PV Operations SME and point of contact for the clinical studies and/or other studies that they support. They will also lead the configuration setup and maintenance of adverse event workflow for the clinical studies and serve as the process owners for the development of department guidance documents, work instructions, and standard operating procedures. The CMS will contribute to the preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents. The Case Management Specialist may assist in adhoc special projects as assigned by the Pharmacovigilance (PV) Operations department management. Essential Functions/Responsibilities Author and maintain robust governance procedures and standards pertaining to ICSR processing, data entry guidelines, coding conventions, and quality review of clinical and/or post marketing) in the Global Safety Database per Jazz standards, global regulatory requirements and industry conventions for corresponding case types. Ensure case processing conventions meet global regulatory requirements as well as the needs of other Jazz Pharmaceutical business areas for signal detection, aggregate data analysis, risk management activities, and periodic safety reports Provide timely responses to regulatory and other pharmacovigilance related queries as appropriate Assist in general oversight and address inquires in central mailbox related to ICSRs from clinical trial, post-marketing solicited and spontaneous sources as appropriate Proactively identify quality control measures to ensure complete and accurate case information has been entered into the drug safety database Collaborate with other cross functional teams to oversee compliance and assist in deviation investigations, root cause analysis and corrective actions Lead and/or assist with safety vendor training Lead clinical study-related/safety management activities including: study startup, study reconciliation, creation of safety management plan and study-closure activities Collaborates with data management and other stakeholders as appropriate for safety data reconciliation Manage pharmacovigilance sections/requirements for the clinical trial master files Adhere to company templates and GxP guidelines for documentation and communications Ensure compliance with corporate and departmental policies, standard operat ng procedures, and timely completion of all assigned training Participate in the development and/or maintenance of PV operations guidance documents related to workflow processes, department policies, work instructions, standard operating procedures and training May assist in adhoc special projects under the direction of the CM department management May serve as an individual contributor, project manager, and/o business process owner for functional projects or workflows May mentor other CM team members, including service providers Participation in Inspections and Audits as required, and maintaining an inspection-ready state of operation Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation, and guidelines Work collaboratively with all stakeholders to identify process gaps, minimize regulatory risks, and recognize patterns of inefficiencies in current operational adverse event management processes Support audits and inspections including backroom activities and maintains inspection readiness Other relevant duties as required to support Case Management Operations and Teams Required Knowledge, Skills, and Abilities Minimum Requirements Min 3 years of pharmaceutical drug safety/pharmacovigilance operations experience (clinical safety experience preferred) Proficient knowledge of Argus safety database and case processing workflow Experience with quality management systems (such as document management, learning management, change control/change management) Strong knowledge of global regulatory requirements for safety reporting. Strong analytical and problem-solving skills with attention to detail Proficiency in standard desktop software programs (Word, Excel, Outlook) Experience using MedDRA and MedDRA coding Understanding of medical terminology and ability to summarize medical information Excellent oral and written communication skills Must be highly organized with an ability to effectively multi-task in a fast paced environment Ability to work independently and as part of a multidisciplinary team Demonstrated accountability for the delivery of results Excellent problem-solving, critical thinking, and decision-making skills Ability to prioritize, plan and organize work assignments while remaining flexible to dynamic timelines Must exhibit a quality, compliance and continuous improvement mindset Flexibility to work outside of normal working hours or on-call arrangements Required/Preferred Education and Licenses BS/BA degree in health-related or biological science-related field required Nursing or PharmD degree preferred

FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $80,000.00 - $120,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depe