Senior Argus Safety Techno-Functional Consultant

• Have in-depth end to end knowledge of Pharmacovigilance Process, well versed with Argus modules.

• Provide Level 2 technical support for a highly customized Oracle Argus Safety application (v8.x), including incident resolution, service requests, and root cause analysis

• Analyze, troubleshoot, and resolve issues related to Argus Core modules, Console configurations, ESM, and Interchange

• Work with partner/vendor teams (e.g., L3 support, infrastructure, middleware) to coordinate resolution of complex technical issues

• Implement minor enhancements such as configuration changes, field updates, workflow adjustments, and dictionary management (MedDRA/WHO-DD uploads)

• Support the maintenance of custom extensions and integrations within the Argus landscape

• Monitor scheduled jobs, perform application health checks, and manage technical logs

• Document all support activities, maintain change logs, and adhere to SOPs and regulatory guidelines (GxP, 21 CFR Part 11)

• Participate in validation testing and impact assessments for small changes

• Provide technical inputs during internal audits or inspection readiness activities, as needed

Required Skills & Experience:

• 10+ years of hands-on experience with Oracle Argus Safety, specifically in technical support and configuration

• Strong understanding of Argus Console, custom configurations, ESM setup, and Interchange/E2B standards

• Ability to analyze PL/SQL queries and navigate the Argus database for issue investigation

• Experience working in a customized Argus environment (non-standard workflows, integrations, or UI modifications)

• Familiarity with ticketing systems like ServiceNow, JIRA

• Experience with ITIL-based support processes

• Understanding of regulatory compliance (GxP, 21 CFR Part 11) and CSV practices