Director, Safety Scientist

2 hours ago


Emeryville, California, United States BeiGene Full time
Job Title: Director, Safety Scientist

Job Summary:

The Director, Safety Scientist will lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. This role requires effective prioritization, critical thinking, and judgment-based decision making to execute key deliverables in compliance with global regulations and internal processes.

Key Responsibilities:
  • 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.
  • Clinical Trial Support: Lead the review of safety data and monitor the safety of patients on allocated clinical trials.
  • Risk Assessment, Regulatory Inquiries, and Periodic Reporting: Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports.
  • Communication and Influence: Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
Requirements:
  • Education: PharmD, NP, RN, or PhD in a medical field or biological science.
  • Experience: 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
  • Skills: Advanced knowledge working with a safety database, MedDRA, and signal management system.
What We Offer:

BeiGene offers a dynamic and supportive work environment, competitive compensation and benefits package, and opportunities for professional growth and development.



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