Associate Director, Safety Scientist

11 hours ago

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

BeiGene is seeking an experienced Associate Director, Safety Scientist to join our team. As a key member of our Safety Science group, you will be responsible for supporting assigned compounds in conjunction with Product Safety Leads (PSLs) and leveraging clinical and scientific expertise to perform signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting.

Key Responsibilities:
  • Lead the identification, analysis, and evaluation of safety data for signal detection from all applicable sources
  • Perform signal detection and signal assessment along with required documentation following BeiGene process
  • Propose and lead data acquisition strategy, methodology, and approach for safety evaluations
  • Lead analysis of safety data and author safety assessment
  • Collaborate with PSLs, Safety Scientists, Pharmacoepidemiologists, and other cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data
  • Execute signal assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee
  • Prepare and support the presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
  • Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions
  • Apply effective communication skills to lead and facilitate safety team meetings
  • Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner
  • Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members
Requirements:
  • PharmD, NP, RN, or PhD in a medical field or biological science and 6+ years of experience as a Safety (Pharmacovigilance) Scientist
  • OR 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 ideally 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred
Preferred Qualifications:
  • Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information
  • Advanced knowledge of MedDRA and signal management system
  • Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva)
  • Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI
Travel:

Less than 10%

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