Signal Management and Risk Consultant

1 day ago

mangalore, India beBeeBusiness Full time

About the RoleWe are seeking an experienced IT-Functional Business Analyst with a strong background in Pharmacovigilance systems.Key Responsibilities:Serve as a senior subject matter expert for Signal Management and Risk Management platforms, owning 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:Demonstrate a deep understanding of Signal Management processes including detection, triage, validation, evaluation, prioritization, and aggregate reporting.Show 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.RequirementsA highly experienced IT-Functional Business Analyst with deep expertise in Pharmacovigilance systems.Strong understanding of Signal Management processes and Risk Management Plans.Excellent communication and problem-solving skills.Ability to work effectively with cross-functional teams.What We OfferA dynamic and supportive work environment.Opportunities for growth and professional development.A competitive compensation package.Other BenefitsFlexible working arrangements.Generous paid time off.A comprehensive benefits package.

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