Senior Pharmacovigilance Business Analyst
4 days ago
Job Title: Senior Pharmacovigilance Business AnalystThis is a high-level position that requires a deep understanding of pharmacovigilance systems, specifically signal management and risk management modules. The ideal candidate will have strong techno-functional capabilities to bridge business requirements with system design, configuration, integrations, and validation activities across the PV technology landscape.Key ResponsibilitiesServe as a senior subject matter expert (SME) for signal management and risk management platforms, with ownership of 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.System Analysis & DeliveryTranslate 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.Process ExpertiseDeep 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.Ensure solutions comply with global PV regulations, audit requirements, and internal quality standards.Collaboration & GovernanceAct as a senior liaison between IT, PV operations, QA, and product vendors.Prepare solution documentation, training materials, and system SOP updates as needed.Provide mentorship/functional guidance to junior BAs and technical team members.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.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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dombivli, India beBeeBusiness Full timeAbout UsWe are a leading healthcare technology firm seeking an experienced Signal Management Business Analyst to join our team.Job DescriptionWe are looking for a highly skilled professional with expertise in Pharmacovigilance (PV) systems, specifically Signal Management and Risk Management modules. The successful candidate will have strong techno-functional...
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Dombivli, India vueverse. Full timeRole SummaryWe are seeking a Senior IT/Tech-Functional Business Analyst with strong expertise in Pharmacovigilance (PV) safety systems, particularly Argus Safety, DLP, and Case Processing workflows. This role focuses on system configuration, enhancements, integrations, validation, and ongoing technical support—not case processing operations.Key...
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Dombivli, India vueverse. Full timeRole SummaryWe are seeking a Senior IT/Tech-Functional Business Analyst with strong expertise in Pharmacovigilance (PV) safety systems, particularly Argus Safety, DLP, and Case Processing workflows. This role focuses on system configuration, enhancements, integrations, validation, and ongoing technical support—not case processing operations.Key...
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Pega Senior Business Systems Analyst
3 weeks ago
Dombivli, India People Prime Worldwide Full timeAbout Company : They balance innovation with an open, friendly culture and the backing of a long-established parent company, known for its ethical reputation. We guide customers from what’s now to what’s next by unlocking the value of their data and applications to solve their digital challenges, achieving outcomes that benefit both business and society....
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