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Senior Argus Safety Techno-Functional Consultant (Praca zdalna)

Hirexa

Poland (Remote), Remote
Zdalna
B2B
CSV
ESM
CFR
Pharmacovigilance
Argus Safety
GXP
MedDRA
💼 B2B
🌐 Zdalna
Pełny etat

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

Wyświetlenia: 36
Opublikowanadzień temu
Wygasaza 29 dni
Rodzaj umowyB2B
Tryb pracyZdalna
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