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2 weeks ago
Tech-Functional Business Analyst RoleJob Summary:We are seeking a highly experienced IT/Tech-Functional Business Analyst (12+ years) with deep expertise in Pharmacovigilance (PV) systems, specifically Signal Management and Risk Management modules. The ideal candidate will possess strong techno-functional capabilities to bridge business requirements with system design, configuration, integrations, and validation activities across the PV technology landscape.Main ResponsibilitiesServe as senior SME for Signal Management and Risk Management platforms, owning system functionality, enhancements, and solutioning.Lead requirement workshops, system impact assessments, and end-to-end functional design for PV applications—primarily ArisG Advanced Signals.Drive solution architecture discussions with IT, vendors, and cross-functional stakeholders.Key TasksTranslate business needs into high-quality BRDs, FSDs, user stories, data mapping specifications, integration requirements, and validation documentation.Oversee configuration, release planning, change requests, and production deployments.Conduct root-cause analysis, troubleshoot complex issues, and manage vendor escalations.Support system upgrades, regression testing strategy, and UAT coordination.Essential Skills and Experience12+ years of total experience, with at least 8+ years in Pharmacovigilance IT / techno-functional roles.Strong hands-on experience with ArisG Advanced Signals and PV safety systems.Proven expertise in drafting system requirements, data flows, interface specifications, and functional design documents.Strong understanding of compliance requirements (ICSR reporting, aggregate signaling, audit readiness).Excellent verbal and written communication skills, with the ability to work with global stakeholders.
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