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Manager, Safety System Management

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: January 15, 2022

Job 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 Argus user access & database changes in collaboration with IT, participation in implementation & testing of system changes.This position will work closely with the Argus Super Users across sites, data listing requestors within Drug Safety, and with business partners from IT and their vendors.Essential Functions

  • 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 Argus 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 neededMinimum Requirements
    • 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 GVPs.
    • 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 preferred.
    • Familiarity with signal detection and pharmacovigilance processes a plus.
    • Familiarity with SQL and relational databases a plus.
    • Prior experience with computerized systems validation preferred.
    • Must be proficient in Microsoft Excel, Word, and PowerPoint; familiarity with MS Project is preferred
    • Must have strong analytical and problem solving skills, with the associated curiosity to enable solving complex problems with little assistance.
    • Must be self-motivated, detail oriented and able to multi-task.
    • Must possess excellent communication (oral and written) skill regarding both medical and technical topics.
    • Must have strong interpersonal/organizational skills.
    • Must maintain superior customer service at all times with all users.
    • Must possess the ability to work in a team environment and follow written policies/procedures.
    • Must be comfortable in a fast-paced, demanding work environment.
    • Flexibility to work outside of normal working hours or on-call arrangements to support the global drug safety organization
    • Limited travel within the US and internationally may be required.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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Manager, Safety System Management, Executive , Palo Alto, California

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