Safety Operation

Department
部门

Medical Office, Research & Development
医学办公室,研发部

Title
职位
Safety Operation Team Lead
药物安全运营团队负责人
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
Safety Operation team members
药物安全运营团队成员
Primary Function
主要职能
  • The Safety Operation Team Lead leads the Safety Operation team and is responsible for all safety operational activities for I-Mab clinical development programs and post-marketing programs globally, for both investigational and marketed products.
  • This role needs to effectively interface cross-functionally within i-Mab organization, with Business Partners, Commercial partners, Contract Research Organizations (CROs), PV vendors, as well as with Regulatory Authorities, to ensure safety data collection, processing, distribution and reporting processes in compliance with company procedures and regulatory requirements.
  • This role needs to develop and ensure company level safety operation processes in place and needs to ensure trainings be delivered to relevant stakeholders to ensure process excellence and compliance. This role supports inspection readiness activities, including internal audits and external inspections.
  • This role needs to have strong leadership. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
  • 药物安全运营团队负责人带领药物安全运营团队负责I-Mab的全球临床开发项目和上市后项目的药物安全运营工作,涵盖公司所有的研究阶段产品和上市后产品。
  • 本岗位需与公司内各职能部门、商业合作伙伴、经营伙伴、CRO、PV服务供应商和药品监管机构有效地接触与沟通,以确保安全性数据的收集、处理、分发和报告程序符合公司流程和法规要求。
  • 本岗位负责制定并确保公司具有完善的安全运营相关的工作流程,且提供相应的培训给到相关方以保证流程优化以及合规。需支持监管机构核查准备就绪工作,包括内部稽查和外部核查。
  • 本岗位应具有很强的领导力;有能力在变化的环境中工作,满足公司及病人的安全需求。
Major Responsibilities and Duties
主要职责和任务

Lead Safety Operation team for below activities:

  • Safety Operational support for i-Mab clinical development programs and post-marketing activities globally, to ensure safety data collection and reporting processes in compliance with I-Mab procedures and regulatory requirements, including but not limited to contribute to the development of Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs), Safety Management Plans, EDC entry guidelines, SAE reconciliation plan, et al, and is responsible for company level and project based safety reporting training and compliance monitoring.
  • Develop company level or Safety operation related processes including policies, Standard Operating Procedures and other relevant safety documentation (e.g. PV system introduction, PV business continuity plan (BCP)), as well as support safety department filing system.
  • Participate in the PV vendor selection activities and contribute to vendor governance and oversight activities, define key performance indicators to ensure PV vendor’s safety operation excellence.
  • Support inspection readiness activities, including internal audits and external inspections.
  • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.
  • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.
  • PV Training and Compliance monitoring activities.

带领药物安全运营团队负责以下工作:

  • 对I-Mab全球的临床开发项目和上市后项目提供药物安全运营方面的支持,以确保安全性数据的收集和报告程序符合公司流程和法规要求,包括但不限于准备药物警戒协议(PVA)或安全数据交换协议(SDEA)、安全管理计划(SMP)、EDC数据录入指南、SAE一致性核对计划等,并负责公司层面和项目层面的安全性报告培训和合规性监测。
  • 准备公司层面或者安全运营相关的流程,包括政策、SOP及其他相关的安全相关的文档(如:PV体系介绍, PV业务连续性计划),以及协助安全部门的文件存档系统。
  • 参与PV服务供应商的选择、管理和监督工作,制定相应绩效考核指标,以确保PV服务供应商安全运营工作高质量完成。
  • 支持监管机构核查准备就绪工作,包括内部稽查及外部核查。
  • 了解监管机构有关PV/安全法规和指南的最新动态。
  • PV培训以及合规性监测。
Qualifications
资格要求
  • Majored in Clinical Medicine or Pharmacology is preferred; Majored in other life science, such as immunology, biochemistry, et al, is acceptable.
  • Minimum 5 years Drug Safety/Pharmacovigilance experience. One to two years clinical development stage PV experience is preferred. ICSR processing experience in global database (for both clinical study cases and post-marketing cases) is preferred. Team management experience is preferred.
  • 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 NMPA, 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.
  • Must have excellent written and oral communication skills in both Chinese and English, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.
  • Some national/international travel may be required.
  • 优选临床医学或药学专业;可接受其他生命科学专业(如免疫学、生物化学等)。
  • 至少5年药物安全/药物警戒经验。拥有1-2年临床研究阶段PV经验者优先。有全球安全收据库中上市前及上市后报告处理经验者优先。有团队管理经验者优先。
  • 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NMPA、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。
  • 优秀的中英文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。