Senior Pharmacovigilance Systems Specialist
2 weeks ago
Job OverviewWe are seeking a seasoned Pharmacovigilance Systems Specialist to lead the analysis, design, and implementation of signal management and risk mitigation systems.Main Responsibilities:Serve as the subject matter expert for signal management and risk management platforms, overseeing system functionality, enhancements, and solutioning.Lead requirement workshops, system impact assessments, and end-to-end functional design for pharmacovigilance applications—primarily ArisG Advanced Signals.Drive solution architecture discussions with IT, vendors, and 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 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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