Requirements & Experience:

• Process ICSRs end-to-end intake to submission
• Ensure case quality, completeness, and accuracy
• Perform MedDRA/WHODrug coding as applicable
• Conduct follow-ups with sites/partners for missing info
• Maintain compliance with timelines and SOPs
• Document narrative summaries and case notes
• Identify and escalate potential safety issues
• Support reconciliation activities and case QC
• Maintain PV trackers and metrics
• Participate in audit readiness and CAPA support