Senior Pharmacovigilance Systems Analyst

2 days ago


karnataka, India beBeePharmacovigilance Full time

Job DescriptionWe are seeking a highly skilled Senior Pharmacovigilance Systems Analyst to join our team. As a key member of our pharmacovigilance group, you will be responsible for configuring, maintaining, and enhancing Argus workflows and integrations.Key Responsibilities:Configure, manage, and optimize Argus Safety modules and workflows.Handle E2B (R2/R3) configuration, testing, validation, and troubleshooting for regulatory reporting.Integrate Argus with external systems using Axway (or other gateway tools).Perform data extraction, validation, and report generation using SQL.Work closely with PV operations, QA, and IT teams to ensure smooth case processing and compliance.Lead system upgrades, patching, migration activities, and UAT.Ensure compliance with global pharmacovigilance regulations and data integrity standards.Provide technical support, issue resolution, and performance optimization.Document configurations, change requests, and system procedures.Required Skills & QualificationsTo be successful in this role, you will need:6–8+ years of experience working with Argus Safety in pharmaceutical or life sciences environments.Strong expertise in E2B Exchange (R2/R3) configuration and validation.Hands-on experience with Axway Gateway for E2B transmission.Proficiency in SQL for data queries, troubleshooting, and analysis.Solid understanding of global PV regulations (FDA, EMA, MHRA, ICH).Experience in Argus upgrades, schema changes, and system validation (CSV).Strong problem-solving, communication, and stakeholder management skills.BenefitsAs a member of our team, you will have the opportunity to work on complex and high-impact pharmacovigilance systems, lead initiatives in PV technology and automation, and collaborate in a growth-focused environment.



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