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
Nice to have
Requirements
Qualifications : B.Tech/M.Tech