Director, Safety Scientist

Role Summary

The Director, Safety Scientist leads safety signal detection, evaluation of safety data, risk assessment, responses to regulatory inquiries, and regulatory-required periodic reporting for assigned compounds, in collaboration with Product Safety Leads. Physicians in this role provide medical safety assessment and apply prioritization, critical thinking, and judgment-based decision making to ensure compliance with global regulations and internal processes. The role requires effective communication and influence with internal and external stakeholders and represents GPS Safety Science at a global level as an authoritative, professional team member.

Responsibilities

• Lead the identification, analysis, and evaluation of safety signals from multiple data sources to determine signals or risks that could affect labels or the 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 proposals for Safety Management Team.
• Lead the preparation and presentation of safety data at safety governance meetings and for related committees.
• Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions.
• Apply effective communication skills to lead and facilitate safety team meetings and drive decision making.
• 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 in collaboration with Safety Science team members and cross-functional teams.
• Lead signal assessment documentation following BeiGene signal management and safety governance framework.
• Lead the review of safety data and monitor the safety of patients on allocated clinical trials.
• Lead the writing and review of safety sections for development documents (Protocols, IBs, ICFs, SAPs, TFLs, Medical Monitoring Plans, CSRs) and respond to ad-hoc safety queries from ethics committees.
• Lead the authoring and review of safety sections of regulatory submissions (IND/CTA, NDA/MAA) in collaboration with PSLs and CST members.
• Lead the authoring of Storyboards and Briefing Books for Health Authority interactions.
• Support ad-hoc review of the Safety Management Plans.
• Lead Safety Science specific investigator training.
• Contribute to 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, and RMPs).
• Lead 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 the impact on safety documents or safety sections of clinical/regulatory documents.
• Lead strategy development and responses to safety questions from health authorities and IRBs/ECs.
• Contribute to integrated Benefit/Risk assessments.
• Promote effective execution, communication, and influence with internal and external stakeholders in pharmacovigilance, contribute to employee development, provide Safety Science training, and identify innovative approaches to improve organizational effectiveness.
• Demonstrate knowledge and application of pharmacovigilance principles to high-complexity tasks and adhere to quality system requirements and regulatory compliance.
• Perform other tasks as assigned by manager to support departmental activities.

Skills

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

Education

• PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
• MD (or internationally recognized equivalent) with accredited residency or completed post-medical school clinical training relevant to the country of hiring; 4+ years of clinical experience with patients 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

• Less than 10% travel