Senior Manager, Safety Scientist

of the Job: Signal and Safety Data Evaluation • Identify, analyze, and evaluate 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 • Support and propose data acquisition strategy, methodology, and approach for safety evaluations • Analyze safety data and author safety assessment reports. • Collaborate with PSLs, 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 strategy and prepare presentations for Safety Management Team and Company Safety Committee • Prepare and present 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 • Support 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 • Perform signal detection and signal assessment along with required documentation following BeOne process Clinical Trial Support • Conduct review of safety data and monitor the safety of patients on allocated clinical trials  Author and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees • Author safety sections and review aggregate reports, e.g., PBRERs, DSURs, PADERs • Support 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 Safety Physicians and other CST members • Support the authoring of Storyboards and Briefing Books for HA interactions • Assist with writing and maintenance of the Safety Management Plans • Support investigator training Risk Assessment, Regulatory Inquiries, and Periodic Reporting • Analyze 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) • Assist with integrated Benefit/Risk assessments Promote and Advance the Field of Pharmacovigilance • Any other tasks assigned by manager to assist in departmental activities Other

• Prior experience as a safety scientist • Pharmaceutical product development experience • Experienced in global regulatory requirements for pharmacovigilance Supervisory Responsibilities: The position has no direct reports. The Senior Manager, Safety Scientist is part of a team that performs high quality and timely scientific and operational safety analysis. This position works closely with the Safety Scientist group as part of a matrix team to conduct safety assessment and safety risk management activities per BeOne process and applicable regulations. Computer Skills: Knowledge working with a safety database for retrieval of safety information; Intermediate knowledge of MedDRA; Advanced application capability with Excel, PowerPoint, and Word. Familiarity with data mining tools and exploratory analyses tools such as Spotfire. Travel: Less than 10% Education Required: PharmD, RN, or PhD in a medical field or biological science and 3+ years of experience in pharmacovigilance in an analytical role 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.