KEY RESPONSIBILITIES:
- 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)
REQUIREMENTS:
- 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
