Requirements & Experience:

• Conduct signal detection activities using PV databases
• Perform quantitative and qualitative signal analyses
• Review case series and safety trends
• Document signal evaluations and decisions
• Present findings to safety governance committees
• Collaborate with epidemiology and medical review teams
• Support risk management and labeling updates
• Maintain signal tracking and documentation systems
• Ensure compliance with GVP and FDA requirements
• Support inspections and regulatory audits