Senior Argus Safety Techno-Functional Consultant
4 tygodni temu
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
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