Tech-Functional Business Analyst – Safety Systems

1 day ago

Dombivli, India vueverse. Full time

Role 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 ResponsibilitiesTech-Functional OwnershipAct as the IT/Systems SME for Argus Safety, DLP, and related safety applications.Lead system requirement gathering, functional design, configuration discussions, and solution documentation.Translate PV safety business processes into system requirements, interface specifications, and functional design documents.System Design & DeliverySupport customization, configuration, and release management of Argus Safety and other PV tools.Work with IT, vendors, and development teams to implement enhancements, fix defects, and optimize system performance.Create and review BRDs, FSDs, user stories, data mapping, and interface design documents.Conduct impact analysis for upgrades, patches, and integration changes.Validation & ComplianceSupport validation activities: test planning, functional testing, regression, and UAT coordination.Ensure Argus and safety systems remain compliant with global PV regulations (ICSR, E2B, reporting rules).Collaborate with QA to maintain audit readiness and documentation.Issue ManagementTroubleshoot system issues (workflow errors, routing failures, E2B transmission issues, reporting deviations).Coordinate with L2/L3 teams and vendors for resolution and root-cause analysis.Cross-Functional CollaborationPartner with Safety Operations, IT, Quality, and Vendor teams for system updates and enhancements.Provide system training and support documentation as required.Required Skills & ExperienceStrong understanding of Safety system business processes (Case Intake, Case Processing, Medical Review, Reporting).Hands-on knowledge of Argus Safety, DLP, workflows, configurations, and system modules.Experience working with safety compliance requirements, including ICSR reporting, E2B(R2/R3), and regulatory reporting.Experience preparing BRDs, FSDs, system design documents, and validation documents.Excellent communication and ability to work across global teams.

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