PV Systems Manager – Reporting and Analytics

Job Category: Technology & IT
Job Type: Permanent
Job Location: Dublin


  • Collaborate with GPS end users develop reporting requirements; document, perform and test reporting updates in the safety systems testing environments
  • Solve user-reported issues of diverse scope
  • Liaise closely with the Global Development Solutions safety systems team and managed service team, in the support and maintenance of GPS systems
  • Contribute to and review user requirements for new GPS systems projects; contribute and review project-related computer systems validation documentation
  • Implement Operational Qualification/Performance Qualification test scripts, in support of safety systems change controls, and in accordance with Good Documentation Practices
  • Generate database searches and output in support of ad-hoc requests for safety data
  • As needed, assist in providing end user training on safety system related updates to internal GPS staff and external partners consuming reporting/analytic output
  • Contribute to the production of system specific metrics and monitoring
  • Collaborate with GDS on continuous improvement opportunities for systems, reports and other end-users focused solutions
  • Implement project specific goals for reporting and/or analytic products
  • Serve as subject-matter expert and steward for delivered reporting, analytic or other delivered solution(s)


  • Strong knowledge of safety database (Argus preferred)
  • Strong knowledge for reporting/business intelligence/visualization tools eg. OBIEE, BusinessObjects, Tableau, Qlik, etc.
  • Knowledge of generating advanced searches (SQL) and developing reporting output
  • Experience in working with case intake systems preferred
  • Experience with configuration and testing of validated systems
  • Knowledge of relevant FDA, EU and ICH (International Conference on Harmonization) regulations governing clinical and post-marketing pharmacovigilance activities
  • Familiarity with concepts of safety surveillance (aka signaling)
  • Working knowledge of PV periodic reporting (eg. DSUR, PBRER, etc.)
  • Working knowledge with analytic environments (eg. R, SAS, Databricks)
  • Familiarity with advanced analytic methodologies
  • Strong written and verbal communication skills, required for frequent communication with both internal and external contacts
  • Ability to prioritize daily tasks independently, and ability to ideate through solutions with business end-users and technical

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