Overview
Support changes and configuration for a global pharmacovigilance safety system and associated data outputs.
What you'll do
- Generate safety system outputs for periodic safety reports and signal detection audits.
- Ensure automated and scheduled safety data outputs are delivered.
- Perform quality checks and peer review for data outputs and routine system configurations.
- Collect business requirements for routine safety data outputs.
- Implement routine safety system configuration, including reporting rule updates and product/study configuration.
- Support study startup, including RAVE-Argus mapping and UAT activities.
- Contribute to training, quick reference guides, and technical solutions for safety database and tools.
What you'll need
- Knowledge of safety systems including LifeSphere MultiVigilance platform/Argus and query/reporting tools such as Cognos and Tableau.
- Understanding of data warehouse concepts and data mining techniques.
- Knowledge of software development lifecycle and validation methodology.
- Understanding of global regulatory requirements for pharmacovigilance and safety reporting.
- Familiarity with clinical trial and pharmacovigilance processes.
- Ability to interpret aggregate safety data using statistical analysis.
- Experience supporting inspections or internal audits.
Read the full description and apply on the company’s own careers page.
