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Senior Business Analyst – Signal & Risk Management

Senior Business Analyst – Signal & Risk Management

vueverse.Kottayam, IN
2 days ago
Job description

Role Summary

We are seeking a highly experienced Senior Business Analyst with deep expertise in Signal Management and Risk Management within Pharmacovigilance. The ideal professional will have strong domain knowledge, a solid understanding of ArisG’s Advanced Signal Management solution, and proven experience supporting safety operations, process optimization, and system enhancements.

Key Responsibilities

  • Serve as the SME for Signal Detection, Signal Validation, Signal Assessment, and Signal Communication processes.
  • Work closely with PV Operations, Medical Safety, and QA teams to refine and enhance signal workflows.
  • Support configuration, requirement gathering, user stories, and documentation for ArisG Advanced Signals .
  • Contribute to Risk Management activities, including Risk Management Plans (RMPs), mitigation strategies, and regulatory expectations.
  • Facilitate cross-functional collaboration to ensure end-to-end alignment of safety processes.
  • Lead UAT cycles, test planning, validation documentation, and release readiness.
  • Drive process improvements and support overall PV system optimization.
  • Conduct user training, knowledge transition, and communication across global teams.

Required Skills & Experience

  • 10+ years of experience in Pharmacovigilance / Drug Safety.
  • Strong expertise in Signal Management business processes .
  • Good understanding of ArisG Advanced Signals solution .
  • Deep knowledge of Risk Management Plans (RMPs) and regulatory expectations.
  • Strong analytical, documentation, and communication skills.
  • Ability to work independently in a remote, global, cross-functional environment.
  • Flexibility to work beyond standard hours when required.
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    Risk Analyst • Kottayam, IN

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