Capgemini
Software Engineer - B
Job Description
Job Description
- Experience in Oracle Argus safety
- Experience in Adverse Event reporting (E2B R2, R3) and profile customization
- Hands on with business and system configurations (Codelist, system configuration, AC, Reporting rule, workflow etc)
- Familiar with Argus Safety Database schema
- Hands on experience in SQL/PL SQL scripts
- Argus Safety user access management, configuration updates, and system maintenance.
- Overseeing the intake, processing, and tracking of adverse event reports in the Argus Safety system
- Provide timely resolution of user issues and service requests
- Understanding of pharmacovigilance regulations and guidelines (e.g., ICH E2B, FDA CFR 21 Part 11 E2B R2 R3 Reporting) and their application to adverse event data management.
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