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Senior Business Analyst – Signal & Risk Management
vueverse.Kurnool, IN1 day ago
Job description10+ 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.
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
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Risk Analyst • Kurnool, IN