General Description:
The 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 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 Specialist performs SAE reconciliation between the safety and clinical databases.

The Specialist is responsible for performing tasks in adherence to internal and external timelines and meeting quality, compliance and productivity target metrics.

Essential Functions of the job:
ICSR Case Management Activities:02

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 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 stakeholders.


SAE Reconciliation:

Perform 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.


Quality and Compliance Indicators:

Meet quality/compliance KPI or metrics.


Productivity and Process Excellence

Meet productivity/volume KPI or metrics.
Execute continuous improvement opportunities within ICSR management.


Vendor/CRO Management

Execute ICSR related activities as described in PV Agreements/Contracts following instruction.

Computer Skills:02 02Argus safety database and other platforms required, MS Office suite, Excel, PowerPoint, Visio, digital skills are preferred.

Other Qualifications:

Experience in drug safety/pharmacovigilance or relevant clinical experience, including training preferred.
Understanding of Global regulatory requirements, PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities preferred.
Understanding of databases, case processing activities, including data acquisition/intake, triage, coding, narrative construction and due diligence activities preferred.
Excellent communication skills (verbal and writing).
Effective time management skills.
Results oriented and strong attention to detail.
Global culture awareness.

020202 02
Education Required:
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.


百济神州全球胜任力
当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。
●团队协作
●提供并征求坦诚及可行的反馈
●自我认知
●兼容并蓄
●积极主动
●开拓精神
●持续学习
●拥抱变化
●结果导向
●分析性思维/数据分析
●卓越财务
●清晰沟通
BeiGene Global Competencies
When we exhibit our values of Patients ***, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
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