Job Description
Title: Senior Specialist, Global ICSR Case Processing & QC
Department: Global Patient Safety
Overview:
Seeking an experienced Senior Specialist in Global ICSR Case Processing & QC 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:
ICSR Case Processing: Manage case processing and quality control of ICSRs from diverse sources (e.g., clinical trials, post-market, literature) to ensure timely, accurate submissions to regulatory authorities. SAE Reconciliation: Perform SAE reconciliations between safety and clinical databases, track progress, resolve issues, and escalate when necessary. Quality & Compliance: Adhere to KPI and quality metrics, e...