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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 member onboarding status.
Support resolving issues or escalate to line manager for new team members.
Study configuration testing
Execute Study configuration testing in safety database, as needed.
Minimum Requirements – Education and Experience:
Minimum bachelor’s degree (major in life sciences, clinical medicine, nursing, pharmacy) or other health care professional or the equivalent combination of relevant education or professional experience. Advanced degree preferred.
Other Experience:
Minimum 5 years' experience in drug safety/pharmacovigilance or relevant clinical experience, including training required.
Strong understanding of Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR 312.32, 314.80, GCP, NMPA Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports and aggregate safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities.
Proficiency in databases, case processing activities, including data acquisition/intake, triage, coding, narrative construction and due diligence activities.
Clinical knowledge of therapeutic area patient populations and drug class.
Experience with effective project and time management strategies to provide high-quality deliverables on time.
Ability to oversee team deliverables and to represent functional responsibilities in audits and inspections.
Excellent communication skills (verbal and writing).
Strong problem-solving skills. Results oriented and strong attention to detail.
Global culture awareness.
Supervisory Responsibilities:
May take team lead responsibilities overseeing team deliverables and supervise staff across multiple GPS sites per business needs.
Mentor team members.
Provide growth and development opportunities.
Contribute to staff recruitment
Travel: 5%
Computer Skills:
Argus safety database and other platforms required, MS Office suite, Excel, PowerPoints, Visio, digital skills are preferred.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
