Oracle Empirica Consultant / PV Signal Management Specialist

Job Summary

We 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 Responsibilities

• Perform signal detection, evaluation, and trend analysis using Oracle Empirica
• Configure and execute data mining runs, queries, and dashboards
• Support signal review meetings and provide analytical insights
• Collaborate with PV, medical, and regulatory teams on safety assessments
• Ensure compliance with global pharmacovigilance regulations (FDA, EMA, Health Canada, etc.)
• Support periodic reporting, documentation, and audit readiness
• Troubleshoot data quality issues and...