长沙招聘

工作职责:

In addition to the above:

1. Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.

2. Quality controls the reportability assessment of ICSR.

3. Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures; forwards the information to the Medical Director for review and processes received information in accordance with project specific instructions.

4. Responsible for effective and efficient development of the safety section of the Safety and Medical Management Plan, including development of specific processes to assure consistency within the project.

5. Supports creation of the SAE/AE reconciliation plan and conducts SAE reconciliation in accordance with this plan and other project specific guidelines.

6. Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports).

7. Supports signal detection and risk management activities.

8. Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.

9. Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.

10. Serves as Lead Drug Safety Associate and coordinates small regional teams of drug safety associates and safety data coordinators on project level (not more than three individuals), serves as the drug safety point of contact for study teams on project level.

11. Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.

12. Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.

13. Proposes solutions for procedural and technical issues.

任职资格:

Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.

1. 2-3 years’ experience in processing of ICSR and/or

2. 2-3 years’ experience as a Clinical Data Coordinator, with at least one year experience as Lead Clinical Data Coordinator.

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。