[Hiring] Senior Specialist, Global ICSR Management @BeiGene

Role Description

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.

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 performs SAE reconciliation between the safety and clinical databases and is responsible for performing tasks in adherence to internal and external timelines while meeting quality, compliance, and productivity target metrics.

Essential Functions

• ICSR Case Management Activities:
  • Independently manage tasks after successful completion of core ICSR case management curriculum and targeted training.
  • Handle all 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).
• SAE Reconciliation:
  • Perform SAE reconciliation between safety and clinical databases.
  • Track SAE reconciliation to ensure completion and adherence to internal and external timelines.
  • 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.

Qualifications

• 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 in Global Patient Safety.
• 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)).
• 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.

Computer Skills

• Argus safety database and other platforms required.
• MS Office suite, Excel, PowerPoint, Visio, digital skills are preferred.

Global Competencies

• 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.