Senior PV System Analyst

6 days ago


india beBeeBusiness Full time

Tech-Functional Business Analyst – SignalJob Summary:We are seeking an accomplished IT/Tech-Functional Business Analyst with a strong background in Pharmacovigilance (PV) systems to join our team. The ideal candidate will have extensive experience in Signal Management and Risk Management modules, as well as a proven track record of delivering high-quality solutions that meet business requirements.Key Responsibilities:Lead the development of system functionality, enhancements, and solutioning for PV applications, primarily ArisG Advanced Signals.Drive requirement workshops, system impact assessments, and end-to-end functional design for PV applications.System Analysis & Delivery:Translate business needs into detailed BRDs, FSDs, user stories, data mapping specifications, integration requirements, and validation documentation.Oversee configuration, release planning, change requests, and production deployments.Process Expertise:Deep understanding of Signal Management processes including detection, triage, validation, evaluation, prioritization, and aggregate reporting.Good knowledge and hands-on involvement in Risk Management Plans (RMP) and associated PV risk mitigation workflows.Collaboration & Governance:Act as a senior liaison between IT, PV operations, QA, and product vendors.Prepare solution documentation, training materials, and system SOP updates as needed.Required Skills & Experience: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.



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