Job Title

Role Summary We are looking for a highly experienced IT/Tech-Functional Business Analyst (12+ years) with deep expertise in Pharmacovigilance (PV) systems, specifically Signal Management and Risk Management modules. The role requires strong techno-functional capability to bridge business requirements with system design, configuration, integrations, and validation activities across the PV technology landscape. Key Responsibilities Tech-Functional Leadership - Serve as the senior 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 & 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.