Basic Function Perform all aspects of the collection, processing, and reporting of adverse events, adhering to all data protection guidelines, Good Clinical Practices (GCPs), regulatory guidelines and required procedures. 职责概要 不良事件的归纳、处理和报告。遵循所有数据保护方针、GCP、监管指南和必要手续。 Major Responsibilities 1. Processes Adverse Events (AEs)/Serious AEs to Standard Operating Procedures (SOPs) and project specific safety plans. · Triages AEs, evaluates AE data for completeness, accuracy, and regulatory reportability. · Enters data into safety/adjudication database. · Performs Quality Control (QC) of entered data. · Codes events, medical history, concomitant medications and tests. · Compiles complete narrative summaries. · Discerns what information requires querying and interacts closely with relevant stakeholders · Participates in generation of reports to the sponsor and regulatory authorities; ensures timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. · Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases. 2. Assists PV manager in the preparation of a safety management plan. 3. Distributes all required periodic reports for both clinical and post-marketing projects. 4. Ensures all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements. 5. Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process. 6. Maintains knowledge of ongoing projects and disease-related terminology. All other responsibilities as assigned Qualifications 1.Bachelor degree or above in medical or pharmaceutical sciences or life science (a degree of clinical medicine is preferred). 2. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet. 3.Some understanding and usage of medical terminology. 4. Ability to be flexible, adapt to change, work independently, as well as part of a team in a complex environment. 主要职责 1.根据SOP和项目安全方针处理不良事件（AE）/严重不良事件。 A 对不良事件进行分类，评估不良事件数据的完整性、准确性和监管报告能力。 B 将数据输入安全/数据库。 C 对输入的数据进行质量控制。 D 代码事件，病史，伴随药物和测试。 E 编写完整的摘要。 F 识别哪些信息需要查询，并与参与方沟通 G 向监管机构提交报告；确保在法规的要求下，及时、一致、准确地报告。 H 与数据管理人员管理临床和安全数据库之间的安全数据信息。 2.协助安全警戒PV经理制定安全管理计划。 3.发布临床和上市后的项目所需的所有定期报告。 4.确保公司的安全数据和处理的各个方面都符合当前行业惯例，并符合所有相关的国内和国际法规要求。 5.充分理解对SOP、工作说明（WIs）、全球药物/生物/器械法规、GCP、ICH指南和药物开发过程的。 6.熟悉正在进行的项目和疾病的相关术语。 7.领导分配的所有其他职责 任职资格 1.医学、药学或生命科学专业本科以上学历（临床医学专业优先）。 2.熟练使用微软办公软件（Word、Excel、PowerPoint）、电子邮件和互联网。 3.理解并能使用医学术语。 4.能灵活应变，适应变化，独立工作，能在复杂环境中融入团队。