上海招聘

Primary Function 主要职能：

The Associate Director of Safety Operation serves as the Safety Operational professional supporting the operational activities from Safety perspective for I-Mab clinical development 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 and reporting processes in compliance with company procedures and regulatory requirements. This role will also support the Global MSOs and Associate Global MSOs, where needed, in medical safety activities. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

药物安全运营副总监作为药物安全运营专业人士，对I-Mab的全球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，涵盖公司研究阶段和上市后的产品。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和报告程序符合公司流程和法规要求。在需要时，将协助全球医学安全负责人（GMSOs）和全球医学安全助理负责人（aGMSOs）的产品医学安全工作。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:

Be responsible for below Safety Operational activities:

负责以下药物安全运营工作：

• Plan and build I-Mab Medical Safety
  Operation Team. Develop I-Mab 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;

规划组建天境医学安全运营团队。起草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；

• 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;

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；

• Participate in the PV vendor selection
  activities and contribute to vendor governance activities and key
  performance indicators to ensure safety operation excellence;

参与PV服务供应商的选择及管理，制定相应绩效考核指标，以确保安全运营工作高质量完成；

• Support inspection readiness activities, including
  internal audits and external inspections;

支持监管机构稽查准备就绪工作，包括内部审计及外部稽查；

• Keeps abreast of new PV/safety regulations
  and guidance from the regulatory authorities;

了解监管机构有关PV/安全法规和指南的最新动态；

• Mentor junior medical office staff;
  develop and provide training within specific areas of knowledge.

指导低年资同事；提供特定领域的培训。

Support Global MSOs and Associate Global MSOs for below activities, where needed:

1) Medical review of individual case safety reports (clinical and spontaneous) and all safety analyses; 2) Preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents to support company projects, including but not limited to protocols, informed consent forms, case report forms (CRFs) and other dossiers for supporting IND/NDA; 3) Support the preparation of pre- and post- marketing aggregate safety reports, including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs); 4) Support 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; 5) Preparation of Risk Management/Control Plans (RMPs/RCPs) for assigned products; 6) other activities, for example, literature searches, Safety Management Team (SMT) meeting logistics.

如需要，协助全球医学安全负责人和全球医学安全助理负责人以下活动：

1）对单个病例（临床试验来源及自发报告）及安全数据分析进行医学审核；2）协助临床、注册及科学文件中安全相关章节的准备和审阅，包括但不限于研究方案、知情同意书、病例报告表及用于支持新药/生物制品临床试验申请或上市申请的其他资料；3）协助准备上市前和上市后累积数据安全性报告的撰写，包括：PSUR/PBRER和DSUR；4）协助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；5）协助风险管理/控制计划撰写；6）其他工作：如文献检索、协助安全管理委员会会议等。

Qualifications 资格要求:

MD is preferred; clinical research and/or fellowship training in oncology, immunology, pharmacology or other relevant specialty is a plus. 优选临床医生；肿瘤学、免疫学、药理学及其他相关专科的临床研究或相关研究培训优先。 Minimum 2-4 years Drug Safety/Pharmacovigilance experience plus 1-2 years clinical development experience; safety operation team management and people management experience are preferred. 至少2-4年药物安全/药物警戒经验并且1-2年临床研究经验; 有安全运营团队管理和人员管理经验优先。 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. 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。 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 有能力在快节奏的工作环境下成功进行多任务管理。 Strong Leadership Skills. 较强的领导力技能。 Must have excellent written and oral communication skills in both Chinese and English, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork. 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。 Some national/international travel may be required. 可能有国内/国外出差需要。

天境生物科技(上海)有限公司
天境生物由臧敬五博士领衔的创新药资深研发团队创建，是一家聚焦在肿瘤免疫和自身免疫疾病精准医疗领域的新药研发生物医药科技公司。
公司的核心竞争力在于早期研发、靶点发现和验证、工艺开发&临床前评价、质量科学&质量管理、早期临床研究的能力（包括临床一期和临床二期）。团队在创新药物靶点生物学、创新抗体药物分子结构研发以及创新药物的转化医学及临床研究方面的优势为公司建立一条具有国际竞争力的项目管线创造了基础。公司目前创新药管线含12个在研创新抗体药物项目。领先的创新药项目将在2017年3月申报临床研究并在台湾, 韩国及中国启动临床研究, 其它项目均已进入细胞株或工艺开发阶段。
公司从成立以来已经建立了广泛深入的国际合作, 如与瑞士FERRING公司合作独家引进开发Olamkicept。公司自主研发的全球创新药项目将在2018年进入中国及美国临床研究申报环节并计划在两地启动一期临床研究。