Oracle Argus Support Specialist
Posted Updated
Summary
Provides L2/L3 support for Oracle Argus Safety Suite in pharmacovigilance operations: incident/problem/change management, RCA, regulatory reporting to FDA/EMA/PMDA, batch monitoring, data reconciliation, and audit readiness. Requires 7-12 years with Argus v8.x+, SQL/PL-SQL, E2B, MedDRA, WHO Drug, and GxP/CSV compliance.
Role & responsibilities
L2/L3 support for Argus Safety Suite ensuring stability, compliance, and PV operations continuity
- Incident, problem & change management
- - RCA & defect resolution
- - Regulatory reporting (FDA, EMA, PMDA)
- - System monitoring & batch job support
- - Data validation & reconciliation
- - Support patches, upgrades & releases
- - Audit readiness & documentation
- - Argus Safety Suite (v8.x+)
- - Pharmacovigilance processes
- - SQL / basic PL-SQL
- - E2B (R2/R3), MedDRA, WHO Drug
- - GxP / CSV compliance
- - Incident management tools
Strong PV operations & regulatory compliance understanding
