Senior Specialist, Global Icsr

Senior Specialist, Global ICSR Case Processing & QC

Title: Senior Specialist, Global ICSR Case Processing & QC.
Overview: Independently manage the processing and quality control of individual case safety reports (ICSRs), ensuring regulatory compliance, data accuracy, completeness, and quality. Duties include SAE reconciliation, meeting compliance and productivity targets, and onboarding new team members.

• ICSR Case Processing: Manage case processing and quality control of ICSDs from clinical trials, post‑market, and literature sources to ensure timely, accurate submissions to regulatory authorities.
• SAE Reconciliation: Perform SAE reconciliations between safety and clinical databases, track progress, resolve issues, and raise escalations when necessary.
• Quality & Compliance: Adhere to KPI and quality metrics, ensuring productivity and continuous process improvement within ICSR management.
• Decision...