Senior Specialist, 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. PLEASE 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 Senior Specialist, Global ICSR Management independently executes the triage of individual case safety reports (ICSRs) to ensure initial assessment of cases is in line with processes and regulations. The Senior Specialist, Global ICSR Management independently executes the case processing and quality control of individual case safety reports (ICSRs) to ensure completeness, accuracy, and quality standards are met for submissions to regulatory authorities and other stakeholders. The Senior Specialist performs SAE reconciliation between the safety and clinical databases. The Senior Specialist is responsible for performing tasks in adherence to internal and external timelines and meeting quality, compliance and productivity target metrics, support decision making and provide training. Essential Functions: ICSR Case Management Activities: Upon successful completion of the core ICSR case management curriculum and targeted training for Triage and Case processing tasks under a mentor's supervision, team members will independently manage the tasks. After achieving the required baseline quality results, the Senior Specialist will be eligible to handle all the workflows (Triage, Case processing, QC) based on case workload and business need from all sources (e.g. clinical trials, post-market spontaneous and solicited sources, literature, etc.) to ensure completeness, accuracy, and quality standards are met for submissions to regulatory authorities and other stakeholde