Tech-Functional Business Analyst – Signal & Risk Management (Pharmacovigilance)

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 applicationsprimarily 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.