Job Description

• Experience in OracleArgussafety
• 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 withArgusSafety 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 theArgusSafety 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.