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Senior Business Analyst - Safety Systems - Argus / DLP / Case Processing

Senior Business Analyst - Safety Systems - Argus / DLP / Case Processing

VUEVERSE CONSULTING SERVICESRemote, India
9 hours ago
Job type
  • Remote
Job description

Role Summary

We are looking for an experienced Senior Safety Business Analyst with strong expertise in Pharmacovigilance systems and business processes. The ideal candidate will have a deep understanding of Argus Safety, DLP activities, case processing workflows, and compliance reporting requirements.

Key Responsibilities :

  • Act as the business SME for Safety systems and PV operations.
  • Lead requirement gathering, documentation, and process mapping for Argus Safety, case processing, and safety reporting.
  • Support system configuration discussions, enhancements, and workflow improvements.
  • Ensure end-to-end compliance with ICSR reporting, regulatory submissions, and quality standards.
  • Drive UAT planning, test scripts creation, execution support, validation, and change control.
  • Work closely with PV, QA, IT, and Compliance teams to streamline safety workflows.
  • Develop BRDs, FRS, User Stories, SOP / Work Instruction updates, and training materials.
  • Support global teams and provide guidance on compliance expectations and best practices.

Required Skills & Experience :

  • 10+ years of experience in Pharmacovigilance / Drug Safety.
  • Strong understanding of Argus Safety, DLP processes, and Case Processing workflows.
  • Solid understanding of compliance requirements (ICSR reporting, expedited submissions, regulatory timelines).
  • Experience with documentation and process mapping (BRDs, FRS, BPMN flows, UAT scripts).
  • Strong communication and stakeholder-management abilities.
  • Ability to operate independently while working with global cross-functional teams.
  • Flexible to manage meetings outside usual working hours.
  • (ref : iimjobs.com)

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