Global Medical Safety Officer (GMSO)

Department
部门

Medical Office, Research & Development
医学办公室,研发部
Title
职位
Global Medical Safety Officer (GMSO)
全球产品医学安全负责人
Starting Date
任职时间

Direct Report
直线经理
China Safety Team Lead
中国药物安全团队负责人
Direct Subordinates
直接下属
None
Primary Function
主要职能

The Global Medical Safety Officer serves as the medical safety expert accountable for the global medical safety strategy and overall safety profile for the assigned products (investigational and marketed) throughout their lifecycle. This role must effectively interface cross-functionally at all levels in the organization, Contract Research Organizations (CROs) as well as with external Regulatory Authorities. This role leads all major pre- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities. This role will work together with other medical safety staff including vendors in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

全球产品医学安全负责人作为医学安全的专家负责相关(研究阶段或上市后)产品整个生命周期内全球医学安全的策略及总体安全性。须与公司内各职能部门、CRO和监管机构有效地接触与沟通。领导所有主要的上市前及上市后安全工作包括安全信号检测、获益-风险评价及风险管理活动。和其他医学安全相关同事包括外部供应商进行药物安全评估,包括个案及累积病例和科学文献进行评估,准备安全报告和与内部及外部相关方有效沟通安全信息。有能力在变化的环境中,满足公司及病人的安全需求。

Major Responsibilities and Duties
主要职责和任务
  • Provide safety leadership for Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and other Programs; liaise with Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
  • Provide safety leadership to Commercial organization to support global launch activities for assigned products if applicable.
  • Lead the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned products.
  • Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.
  • Lead signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders.
  • Chair product Safety Management Team (SMT), Product Benefit Risk Committee (PBRC), and other executive forums for assigned products.
  • Contribute to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products.
  • Lead risk-benefit evaluations and contribute to preparation of Risk Management/Control Plans (RMPs/RCPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.
  • Provide medical review of individual case safety reports (clinical and post-marketing) and all safety analyses to ensure accurate coding, seriousness, expectedness and company causality assessment, appropriate medical interpretation, consistency in case assessment and accurate reporting to Health Authorities, Ethics Committees, and business partners.
  • Develop or contribute to development of I-Mab or department processes including policies, Standard Operating Procedures and other relevant safety documentation (eg. Safety Management Plans, data entry guidelines, etc.).
  • Actively involved in inspection readiness activities, internal audits and external inspections.
  • Participate in the PV vendor selection activities and contribute to vendor governance activities and key performance indicators to ensure safety operation excellence; contribute to the generation of Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs).
  • Provide safety expertise to due diligence activities as needed.
  • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.
  • Mentor junior medical office staff; develop and provide training within specific areas of knowledge.
  • 在临床研究、研究者申办的研究、同情用药及其他项目中作为安全方面的主导;与临床开发、临床运营、医学事务、生物统计、注册事务、CROs、数据监察委员会(DMC)及其他机构合作,使安全策略能得到有效地执行。
  • 在药物上市活动中与商业团队合作,主导安全方面的工作和支持。
  • 主导临床、注册及科学文件中安全相关章节的准备和审阅,包括:研究方案、知情同意书/评估表、病例报告表、统计计划、临床研究报告/概要、安全汇总、新药/生物制品上市申请、市场许可申请、CTD递交、监管机构问询回复、IRB/EC回复、综述资料及待发表文献等,以确保产品安全性得到正确地反映。
  • 主导构建及维持核心安全性信息,确保其在所有安全参考信息相关文件中正确执行,包括研究者手册、公司核心数据表、各国包装标签和其他相关产品标签。
  • 主导所负责产品的安全信号检测活动,确保安全信号的识别、评价、验证,包括单个病例和累积病例分析;解释安全信号及趋势;与内外部相关方协作进行安全风险评估的记录和沟通(书面和口头)。
  • 主持产品安全管理委员会,产品获益风险委员会和其他相关委员会。
  • 参与准备上市前后累积数据安全性报告的撰写,包括:PSUR/PBRERPADERDSURIND年度报告,6个月SUSAR行列表,确保上述报告中所负责产品的产品安全性概况或信息沟通的一致性。
  • 主导所负责产品的风险-获益评价,参与风险管理/控制计划(RMP/RCP)撰写,确保风险识别、风险最小化和有效性评估符合相关法规要求。
  • 审核单个病例(临床试验及上市后来源)及安全分析,确保向监管部门、伦理委员会和商业合作伙伴提供的报告在术语编码、严重性、预期性、公司因果关系评价及医学解释方面的准确性和一致性。
  • 创建或参与创建公司/部门流程,包括政策、SOPs和其他安全相关文件(如安全管理计划,数据录入指南等)。
  • 积极参与监管机构稽查,内部及外部审计。
  • 参与PV供应商的选择及管理工作,参与制定相应绩效考核指标,以确保安全运营工作质量;参与PVA或SDEA审核。
  • 在尽职调查中提供安全支持。
  • 了解监管机构有关PV/安全法规和指南的最新动态。
  • 指导低年资同事;提供特定领域的培训。
Qualifications
资格要求
  • MD is preferred; clinical research and/or fellowship training in oncology, immunology, genetics, pediatrics, pharmacology or other relevant specialty is a plus.
  • Minimum 5 years Drug Safety/Pharmacovigilance experience plus 2 years clinical development experience; other relevant experience may be considered.
  • Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to China, Americas, European Union and Asia-Pacific territories including a thorough understanding of case processing and other pharmacovigilance processes. Exposure to working relationship with the CFDA, FDA and other regulatory authorities is preferred.
  • Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position.
  • Strong leadership skills.
  • Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.
  • Some national/international travel may be required.
  • 优选临床医生;肿瘤学、免疫学、遗传学、儿科、药理学及其他相关专科的临床研究或相关研究培训优先。
  • 至少5年药物安全/药物警戒经验, 2年临床研究经验; 或其他相关经验。
  • 充分了解全球PV监管环境,对中国,美洲,欧洲及亚太地区的法规,标准和GVP有实际工作认识。与CFDA,FDA及其他监管机构有工作接触优先。
  • 有能力在快节奏的工作环境下成功进行多任务管理。
  • 较强的领导力技能。
  • 优秀的书面和口头沟通技能,善于取得资源,个人管理能力,跨部门工作能力。
  • 可能有国内/国外出差需要。