Signal Management Analyst

2 days ago

vellore, India beBeeBusiness Full time

Senior IT Business Analyst - PharmacovigilanceOur organization is seeking a seasoned IT business analyst to lead signal management and risk assessment in the Pharmacovigilance domain. This role demands strong techno-functional skills bridging business needs with system design, integrations, and validation.Key Responsibilities:Lead requirement workshops, system impact assessments, and functional design for PV applications like ArisG Advanced Signals.Drive solution architecture discussions with cross-functional stakeholders.System Analysis & Delivery: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.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.Ensure solutions comply with global PV regulations, audit requirements, and internal quality standards.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.Provide mentorship/functional guidance to junior BAs and technical team members.Required Skills & Experience:• 12+ years total experience, 8+ years in Pharmacovigilance IT / techno-functional roles.• Strong ArisG Advanced Signals experience and PV safety systems expertise.• Proven drafting skills for system requirements, data flows, interface specs, and functional design documents.• Excellent verbal and written communication skills, working with global stakeholders.

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