Job Title

Job SummaryWe are seeking an experienced Oracle Empirica professional to support pharmacovigilance signal detection and safety analytics activities. The role involves working closely with PV scientists and safety teams to analyze safety data, support signal management, and ensure regulatory compliance.Key ResponsibilitiesPerform signal detection, evaluation, and trend analysis using Oracle EmpiricaConfigure and execute data mining runs, queries, and dashboardsSupport signal review meetings and provide analytical insightsCollaborate with PV, medical, and regulatory teams on safety assessmentsEnsure compliance with global pharmacovigilance regulations (FDA, EMA, Health Canada, etc.)Support periodic reporting, documentation, and audit readinessTroubleshoot data quality issues and system-related challengesRequired Skills & Experience5-10 years of experience in Pharmacovigilance / Drug SafetyStrong hands-on experience with Oracle Empirica (Signal or Topics)Solid understanding of ICSRs, signal management, and safety workflowsExperience working with large safety datasets and statistical outputsFamiliarity with global regulatory guidelines (ICH, GVP, FDA)Ability to work independently in a remote environmentStrong communication and stakeholder collaboration skills