南京招聘

Major Responsibilities: 

1.    Enters information into ICSR tracking sheet for receipt and submission of safety report.

2.    Processes ICSRs according to Standard Operating Procedures (SOPs), Working Instructions (WIs) and safety database user manual

·      Receives and documents incoming safety report from all sources.

·      Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.

·      Enters data into safety database.

·      Codes events, medical history, indications of medications, concomitant medications and tests.

·      Compiles complete narrative summaries.

·      Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.

·      Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.

3.    Completes distribution of all required individual expedited and periodic reports for both clinical and post-marketing products within required timeline.

4.    Assists in the preparation of the Safety Management Plan.

5.    Participates in audit/inspection as required.

6.    Ensures all relevant documents are stored appropriately per company SOP.

7.    Performs literature search and review.

8.    Maintains understanding and compliance with SOPs, WIs, PV related global and local legislation and regulations, ICH guidelines.

9.    Coordinates with data management staff concerning SAE reconciliation between the clinical and safety databases.

10. Liaises with partners and other stakeholders regarding safety data collection and reconciliation.

11. Completes other tasks assigned by line manager.

Requirements:

1.    Bachelor’s degree or above in life science, medical, medicine or equivalent with minimum of 1 year of pharmaceutical/biotechnology PV case processing experience, including clinical trial and post-marketing experience.

2.    Familiar with clinical trial process across Phase I-IV, PV related legislation and regulations, ICH guidelines.

3.    Strong communication and presentation skill.

4.    Able to work on multiple tasks and projects.

5.    Detail oriented with high degree of accuracy.

6.    Good time management skill and able to meet deadlines.

传奇生物（NASDAQ: LEGN）是一家处于临床阶段的全球生物制药公司，专注于肿瘤和其他领域的新型细胞疗法的开发。目前，公司在中国、美国、欧洲拥有800多名员工。运用创新的技术手段、全球研发模式、生产策略和专业知识，公司具备强大的潜力为患者开发和制造一流的细胞疗法。传奇生物通过战略合作开发和商业化旗下主导产品西达基奥仑赛（cilta-cel），这是一种靶向BCMA的CAR-T细胞疗法用于治疗多发性***瘤患者，该药物目前正处于注册临床试验阶段。