Job Information
BeiGene Director, Safety Scientist in San Mateo, California
General Description:
The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead 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 are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your manager regarding your actual job responsibilities and any related duties that may be required for the position.
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
Define data acquisition strategy, methodology, and approach for safety evaluations
Perform analysis of safety data and lead authoring of safety assessment
Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy
Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team
Lead the preparation and 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 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 (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
Lead signal assessment documentation following BeiGene signal management and safety governance framework
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, Safety Analysis Plans (SAPs), Tables Figures and Listings (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 PSLs and other Clinical Study Team (CST) members
Lead the authoring of Storyboards and Briefing Books for HA interactions
Support ad-hoc review of the Safety Management Plans
Lead Safety Science specific investigator training
Risk Assessment, Regulatory Inquiries, and Periodic Reporting
Lead analysis of 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 Report (PAER), Periodic Safety
Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs)
Lead and demonstrate ability to resource, plan, and fulfill additional evaluation requests with quality from health authorities (e.g., PRAC PSUSA) for assigned compounds
Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents.
Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs.
Author Health Hazard Evaluations
Contribute to integrated Benefit/Risk assessments
Promote and Advance the Field of Pharmacovigilance
Responsible for effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies)
Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning
Contribute to and provide Safety Science training to support team development
Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity
Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity
Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations
Execute any other tasks assigned by manager to assist in departmental activities
Supervisory Responsibilities:
This position may have direct reports depending on the program / portfolio being led. The Director, Safety Scientist provides key support as an experienced safety scientist that leads and performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations and provides a high degree of support to assigned compounds and line manager.
Education Required:
PharmD, NP, RN, or PhD in a medical field or biological science and 8+ 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 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.
Computer Skills:
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
Other Qualifications (Experience and Knowledge):
Prior matrix management team experience
Clinical knowledge of various disease states, drug effects, human physiology and pharmacology
Demonstrated ability to prioritize and manage multiple deliverables simultaneously
Demonstrated leadership, organizational and administrative skills
Prior experience with Regulatory Agency interactions
Pharmaceutical product development experience, including individual study design and filing plans
Experienced in global regulatory requirements for pharmacovigilance
Travel: Less than 10%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.