Job description
- Configuring, administering, and validating Oracle Argus Safety and other Pharmacovigilance/Safety systems.
- Performing system installation, configuration, upgrades, and customizations based on business and regulatory needs.
- Developing and executing SQL and PL/SQL scripts to support system configuration, reporting, and data management.
- Configuring and supporting Argus Aggregate Reporting and Periodic Reporting functionalities.
- Ensuring compliance with regulatory standards including 21 CFR Part 11, ICH guidelines, and GxP requirements.
- Managing Argus business and system configurations to support end-to-end pharmacovigilance operations.
- Executing SIT and UAT as part of implementation and upgrade projects.
- Applying knowledge of global pharmacovigilance regulations including EU, FDA, MFDS, NMPA requirements.
Skills
Oracle Argus× Argus Configuration× System Administration× System Validation× Installation & Upgrades×
Nice to have
Oracle ArgusArgus ConfigurationSystem AdministrationSystem ValidationInstallation & UpgradesSystem CustomizationSQLPL/SQLAggregate ReportingPeriodic ReportingBusiness ConfigurationSystem ConfigurationSITUAT21 CFR Part 11ICH GuidelinesGxP CompliancePV Regulations.
Requirements
Qualifications: B.Tech/M.Tech