General Description:
The Senior Specialist, Global ICSR Triage 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 performs SAE reconciliation between the safety and clinical database.
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 of the job:0202
ICSR Case Processing Activities:
Execute the activities of triage of individual case safety reports (ICSR) from all sources (e.g. clinical trials, post-market spontaneous and solicited sources, literature, etc.) to ensure accurate preliminary case assessment for the prioritization of cases in workflow. Assist with case processing and quality control activities, as needed.
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.
Demonstrate problem solving capabilities and execute continuous improvement opportunities within ICSR management.
Decision Making:
Make process decisions consistent with operational policies, SOPs and WIs.
Vendor/CRO Management
Execute ICSR related activities as described in PV Agreements/Contracts following instruction.
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.
Computer Skills: Argus safety database and other platforms required, MS Office suite, Excel, PowerPoint, Visio, digital skills are preferred.
Other Qualifications: 0202
Minimum 2 years experience in drug safety/pharmacovigilance or relevant clinical experience, including training required.
Understanding of Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement (No. 66, 2018), 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.
Understanding of databases, case processing activities, including data acquisition/intake, triage, coding, narrative construction and due diligence activities.
Excellent communication skills (verbal and writing).
Strong problem-solving skills.
Effective time management skills.
Results oriented and strong attention to detail.
Global culture awareness.
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 First, 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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