Manager, Global ICSR Management

📋 Description

• Oversee ICSR triage, case processing, inline quality control, workflow management, and timely
• Lead SAE reconciliation between safety and clinical databases; identify discrepancies and
• Establish, monitor, and analyze KPIs; partner with process excellence teams for root cause analysis
• Drive continuous improvement across ICSR management: process optimization, productivity
• Review workflow and prioritization; balance workloads to meet timelines and regulatory targets.
• Mentor team members and contribute to recruitment and leadership across global sites as needed.

🎯 Requirements

• Bachelor’s degree in life sciences or healthcare; advanced degree preferred.
• At least 5 years in drug safety/pharmacovigilance or related clinical operations, including
• Strong knowledge of global pharmacovigilance/regulatory requirements (ICH, GVP, FDA, GCP, NMPA/CDE).
• Experience supporting pharmacovigilance reporting to FDA, EMA, MHRA, CDE/NMPA, and other
• Hands-on understanding of ICSR processing (data intake, triage, coding, narrative, follow-up, due
• Experience with Argus Safety or similar safety databases; proficient with MS Office (Excel