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 timelines.
- Analyze and resolve issues with quality/compliance KPI or metrics including root cause analysis, late case investigation and determining actions to correct issues.
Productivity and Process Excellence
- Monitor productivity/volume KPI or metrics.
- Set, define and generate productivity/volume KPI or metrics
- Analyze and resolve productivity issues.
- Manage the execution of continuous improvement opportunities within ICSR Management with support from senior manager.
- Serve as business lead for process excellence, continuous improvement, productivity and technology efficiencies initiatives with support from senior manager
Workflow Management:
- Review ICSR in workflow to ensure completion of cases within internal and external timelines.
- Resolve or escalate case prioritization and case processing questions.
- Balance team workload and ensure target KPIs are met.
Decision Making, Process Evaluation & Documentation
- Make process decisions for escalated issues regarding operational policies, SOPs and WIs.
- Contribute to changing operational policies, SOPs and WIs.
- Analyze and drive changes to existing processes and procedures.
- Assist in creation of new procedural documents with support from senior manager.
Audit & Inspection Support
- Act as SME in audits and inspections with support from senior manager.
- Execute audit/inspection readiness activities.
Vendor/CRO Management
- Communicate signed PV Agreement/Contract information to team.
Cross-Functional Collaborations & Ad-hoc Requests
- Lead critical process or sub-process areas and project initiatives within GPS organization
- May lead and/or participate as ICSR Management subject matter expert (SME) on cross functional projects (outside the GPS) organization as needed.
Training & Onboarding
- Deliver training to new team members.
- Develop and update training materials.
- Provide feedback to line manager for review about new team me