Senior Specialist, Global Icsr

Senior Specialist, Global ICSR Case Processing & QC

Senior Specialist, Global ICSR Case Processing & QC

Seeking an experienced Senior Specialist to independently manage the processing and quality control of individual case safety reports (ICSRs), ensuring regulatory compliance and excellence in data accuracy, completeness, and quality. The role includes SAE reconciliation, meeting compliance and productivity targets, and supporting onboarding and training for new team members.

Key Responsibilities

• Manage case processing and quality control of ICSPR from diverse sources to ensure timely, accurate submissions to regulatory authorities.
• Perform SAE reconciliations between safety and clinical databases, track progress, resolve issues, and elevate when necessary.
• Adhere to KPI and quality metrics, ensuring productivity and process improvement within ICSR management.
• Execute decisions in line with operational polic...