Associate Director, Safety Scientist

Essential Functions Of The Job

• Signal and Safety Data Evaluation
  • Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile
  • Propose and lead data acquisition strategy, methodology, and approach for safety evaluations
  • Lead analysis of safety data and author safety assessment reports
• Clinical Trial Support
  • Lead the review of safety data and monitor the safety of patients on allocated clinical trials
  • Lead the writing and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, SAPs/TFLs, Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees
  • Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with Safety Physicians and other CST members
  • Lead the authoring of Storyboards and Briefing Books for HA interactions
  • Lead Safety Science specific investigator training
• Risk Assessment, Regulatory Inquiries, and Periodic Reporting
  • Analyze safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/Periodic Adverse Experience
• Supervisory Responsibilities
  • The position has no direct reports.
  • The Associate Director, Safety Scientist is part of a team that performs high quality and timely scientific and operational safety analysis.
  • This position works closely with the Safety Scientist group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations.

Required Education

• PharmD or PhD in a medical field or biological science and 4+ years of experience in pharmacovigilance in an analytical role
• RN with 8+ years in pharmacovigilance in an analytical role.
• MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring.
• 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.
• US trained physicians must have achieved board eligibility or certification.
• Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Safety Officer or appropriate delegate.

Computer Skills

• Intermediate knowledge working with a safety database for retrieval of safety information.
• Advanced knowledge of MedDRA.
• MS Office Suite: Advanced application capability with Excel, PowerPoint, and Word.
• Familiarity with data mining tools and exploratory analyses tools such as Spotfire.

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