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If you are a 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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description: The Manager, Safety System Management will be responsible for the management of safety data-related activities in the Drug Safety team such as, but not limited to, generating listings from the safety database, peer review of safety database queries, coordinating safety systems user access & database changes in collaboration with IT, participation in implementation & testing of system changes. This position will work closely with the safety systems Super Users across sites, data listing requestors within Drug Safety, and with business partners from IT and their vendors. Essential Functions/Responsibilities Excellent working knowledge on pharmacovigilance and drug safety regulations (ICH, GxP) Work to streamline and optimize business processes based on industry best practices. Generate listings from the safety database, both standard reports and ad hoc queries. Conduct peer review of safety database queries for accuracy and completeness of the results. Coordinate safety systems user access & database changes in collaboration with IT. Participate in implementation & testing of system changes, which may include preparation and execution of test scripts. Work closely with the Drug Safety case processing team to ensure consistent data entry processes across all products. Participate in updating the data entry manual and associated work instructions when new and/or updated conventions are introduced and train the staff as appropriate. Proactively screen ICSRs for data consistency and identify areas of opportunity to enhance data entry processes. Work closely with IT and their vendors and Drug Safety staff to troubleshoot, configure, and administer functions on our business applications. Collaborate and coordinate with cross-functional team members to assist in the design, review and creation of high-quality safety database output/listings. Develop systems for organizing data to analyze, identify and report data and trends. May represent Safety systems Management in project team meetings. May review clinical protocols to identify impact on safety database, and initiate change requests as appropriate. Support remote and local case processing staff on data-related issues as needed. Proactively screen ICSRs for data consistency and identify areas of opportunity to enhance data entry processes. Required Knowledge, Skills, and Abilities Bachelor's degree and a minimum of three years of experience in supporting Drug Safety case management processes in a pharmaceutical company, or equivalent. Must have a good understanding of Drug Safety regulations specifically US FDA and the EU Must have experience working with standard safety software, with preference for Argus Safety. Experience with reporting tools such as Tableau, Spotfire, Cognos, or Business Objects Familiarity with signal detection and pharmacovigilance processes a plus. Familiarity with SQL and relational databases a plus. Prior experien