Director, Safety Scientist

Role Summary

The Director, Safety Scientist supports assigned compounds with Product Safety Leads and leads the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role provide medical safety assessment. The role requires prioritization, critical thinking, and judgment-based decision making to ensure compliance with global regulations and internal processes. Strong communication with internal and external stakeholders is essential, and the role represents GPS Safety Science at a global level within relevant teams.

Responsibilities

• Signal and Safety Data Evaluation
  • Lead identification, analysis, and evaluation of safety signals from multiple data sources to determine signals or risks that could change labels or benefit–risk profile.
  • Define data acquisition strategy, methodology, and approach for safety evaluations.
  • Perform analysis of safety data and lead authoring of safety assessments.
  • Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel to ensure thorough evaluation and aggregate analysis of safety data.
  • Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendations for action and proposed Safety Management Team.
  • Lead preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), DMC/DSMB.
  • Apply judgment-based decision-making to contribute to scientific/clinical discussions.
  • Lead and facilitate safety team meetings and drive decision making; communicate relevant safety information to core team and stakeholders in a timely manner.
  • Lead development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator’s Brochure, DHCP letters, labeling documents, Risk Management Plan) in collaboration with Safety Science and cross-functional teams.
  • Lead signal assessment documentation following BeiGene signal management and safety governance framework.
• Clinical Trial Support
  • Lead the review of safety data and monitor safety of patients on allocated clinical trials.
  • Lead the writing and review of safety sections and provide safety expertise for Protocols, IBs, ICFs, SAPs, TFLs, Medical Monitoring Plans, CSRs (including China ADR Summary) and other project documents; answer ad-hoc safety queries from ethics committees.
  • Lead the authoring and review of safety sections of regulatory submissions (IND/CTA, NDA/MAA) collaborating with PSLs and CST members.
  • Lead the authoring of Storyboards and Briefing Books for HA interactions.
  • Support ad-hoc review of Safety Management Plans.
  • Lead Safety Science specific investigator training.
  • Risk assessment, regulatory inquiries, and periodic reporting.
  • Lead analysis of safety data and author safety sections of global regulatory inquiries and periodic reports (DSURs, PADER/PAER, PSURs, PBRERs, RMPs).
  • Lead resource planning and fulfill additional evaluation requests with quality from health authorities (e.g., PRAC PSUSA) for assigned compounds.
  • Identify safety-related questions from inquiries and assess impact on safety documents or safety sections of clinical/regulatory documents.
  • Lead strategy development and response to safety questions from health authorities and IRBs/ECs.
• Author Health Hazard Evaluations
  • Contribute to integrated Benefit/Risk assessments.
• Promote and Advance the Field of Pharmacovigilance
  • Execute and communicate effectively with internal and external stakeholders (clinical development, medical, regulatory, labeling, FDA, MHRA, EMA, etc.).
  • Contribute to continuous employee development programs, mentoring, coaching, and peer-to-peer learning.
  • Provide Safety Science training to support team development.
  • Identify and develop innovative approaches to improve organizational effectiveness and productivity.
  • Demonstrate knowledge and application of pharmacovigilance principles to high-complexity tasks.
  • Adhere to quality system requirements and process improvements to ensure compliance with internal processes and regulations.
  • Execute other tasks as assigned by manager to assist in departmental activities.
• Supervisory Responsibilities
  • This position may have direct reports depending on the program/portfolio; provides support as an experienced safety scientist leading and performing high-quality safety analysis, working with the Safety Science group in a matrix environment, and supporting assigned compounds and line manager.

Skills

• Advanced knowledge of safety databases (e.g., Argus) for retrieval of safety information.
• Advanced knowledge of MedDRA and signal management systems.
• Advanced proficiency with Excel, PowerPoint, Word, and electronic document management systems (e.g., Veeva).
• Advanced knowledge of data mining and analysis tools (e.g., Spotfire, PowerBI).

Education

• PharmD, NP, RN, or PhD in a medical field or biological science with 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
• MD (or internationally recognized equivalent) with accredited residency or equivalent clinical training; 4+ years of clinical patient experience in a relevant therapeutic area; and 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.

Additional Requirements

• Travel: Less than 10%