Senior Pharmacovigilance IT/Techno-Functional Business Analyst

2 days ago


erode, India beBeePharmacovigilance Full time

Job DescriptionWe are seeking an experienced IT/Tech-Functional Business Analyst with a strong background in Pharmacovigilance (PV) systems to join our team.This role requires a highly skilled individual with expertise in Signal Management and Risk Management modules, as well as experience working with PV safety systems.The ideal candidate will have strong techno-functional capability to bridge business requirements with system design, configuration, integrations, and validation activities across the PV technology landscape.The successful candidate will lead requirement workshops, system impact assessments, and end-to-end functional design for PV applications—primarily ArisG Advanced Signals. They will drive solution architecture discussions with IT, vendors, and cross-functional stakeholders.Key Responsibilities:Translate 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.Required Skills & QualificationsWe are looking for candidates with the following skills and qualifications:12+ 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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