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Tech-Functional Business Analyst – Safety Systems (Argus, DLP, Case Processing)

Tech-Functional Business Analyst – Safety Systems (Argus, DLP, Case Processing)

vueverse.Kottayam, IN
5 hours ago
Job description

Role Summary

We are seeking a Senior IT / Tech-Functional Business Analyst with strong expertise in Pharmacovigilance (PV) safety systems, particularly Argus Safety , DLP , and Case Processing workflows . This role focuses on system configuration, enhancements, integrations, validation, and ongoing technical support—not case processing operations.

Key Responsibilities

Tech-Functional Ownership

  • Act as the IT / Systems SME for Argus Safety, DLP, and related safety applications.
  • Lead system requirement gathering, functional design, configuration discussions, and solution documentation.
  • Translate PV safety business processes into system requirements, interface specifications, and functional design documents .

System Design & Delivery

  • Support customization, configuration, and release management of Argus Safety and other PV tools.
  • Work with IT, vendors, and development teams to implement enhancements, fix defects, and optimize system performance.
  • Create and review BRDs, FSDs, user stories, data mapping, and interface design documents .
  • Conduct impact analysis for upgrades, patches, and integration changes.

    • Validation & Compliance

  • Support validation activities : test planning, functional testing, regression, and UAT coordination.
  • Ensure Argus and safety systems remain compliant with global PV regulations (ICSR, E2B, reporting rules).
  • Collaborate with QA to maintain audit readiness and documentation.

    • Issue Management

  • Troubleshoot system issues (workflow errors, routing failures, E2B transmission issues, reporting deviations).
  • Coordinate with L2 / L3 teams and vendors for resolution and root-cause analysis.

    • Cross-Functional Collaboration

  • Partner with Safety Operations, IT, Quality, and Vendor teams for system updates and enhancements.
  • Provide system training and support documentation as required.

    • Required Skills & Experience

  • Strong understanding of Safety system business processes (Case Intake, Case Processing, Medical Review, Reporting).
  • Hands-on knowledge of Argus Safety , DLP , workflows, configurations, and system modules.
  • Experience working with safety compliance requirements, including ICSR reporting , E2B(R2 / R3), and regulatory reporting.
  • Experience preparing BRDs, FSDs, system design documents, and validation documents.
  • Excellent communication and ability to work across global teams.
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    System Analyst • Kottayam, IN