Manager, Global ICSR Management

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. LEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION Language Requirement : Fluent English is Required Preferred Experience : Pharmaceutical/Biotech Industry Location : Brazil Remote General Description: The Manager, Global ICSR Management oversees triage, case processing and in-line quality control focusing on efficiency, quality & compliance. The Manager, in consultation with the Process Excellence team, is responsible for monitoring, defining, and setting metrics and determining course of action to resolve any issues. The Manager has decision-making authority to clarify ICSR issues related to governance documents rising from the ICSR team. The Manager will also represent GPS Safety Operations in cross functional projects related to ICSR activities, as needed. The Manager will provide support, as needed, in audits and inspections. Essential Functions: ICSR Case Management activities Monitor the activities of triage, case processing, and quality control of individual case safety reports (ICSR) to ensure timely completion of activities and assist with execution of activities if needed. SAE Reconciliation Oversee, analyze, drive change to SAE reconciliation process. Support and assist with SAE reconciliation between safety and clinical databases. Track SAE reconciliation to ensure completion and adherence to internal and external timelines and resolve or escalate issues with SAE reconciliation. Review SAE reconciliation plan. Quality and Compliance Indicators Monitor quality/compliance KPI or metrics. Set and define quality/compliance KPI or metrics (with Process Excellence team). Generate metrics for quality and compliance to meet internal and external timeli