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Associate Director, Safety Scientist
1 month ago
General Description: The Associate Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages 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. 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 is an important capability 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 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, demonstrating the ability to understand and communicate scientific issues and strategy 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 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 Support 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 the 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) Provide high quality support and fulfill additional evaluation requests 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. Support 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 Contribute to 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 Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are medium 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 has no direct reports. The Associate Director, Safety Scientist is part of a team that 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. Competencies: Time Management and Prioritization – Identify and prioritize tasks based on urgency and importance; effectively allocate time to tasks and activities to meet deadlines, maximize productivity and achieve goals. Demonstrate Initiative – Makes bold commitments and delivers against them; action-oriented; acts autonomously and makes sound decisions; anticipates and addresses challenges Analytical Thinking/Data Analysis – Identifies, collects and analyzes data to drive insights; applies intuition, experience, and judgement to draw logical conclusions to present for use in decision making Results-Oriented – Directs attention and resources towards what’s important; focuses on outcomes not activities; relentlessly sets and achieves goals with integrity and following compliance standards, able to influence results in matrix environment Communicates with Clarity – Clearly and consistently communicates with peers, collaborators, and leadership; listens and responds to feedback; checks for understanding; communicates with cultural sensitivity Actionable Feedback – Openly and ongoingly solicits feedback from others to enhance performance, provides constructive and honest feedback to others Fosters Teamwork – Solicits input from diverse sources and collaborates effectively; puts BeiGene’s and patients’ interests ahead of one’s own interests; values the opinions of others 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: Pharmaceutical product development experience Experienced in global regulatory requirements for pharmacovigilance Travel: Less than 10% Education Required: 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. 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.
