长沙招聘

1. Receives (by fax, e-mail or phone call) and processes individual case safety reports (ICSR; e.g. serious adverse events, adverse events of special interest, and suspected ADRs) from clinical trial, spontaneous and from published reports (e.g. from the literature, received from Regulatory Authorities).

2. Generates concise, accurate and well-written case narratives.

3. Performs consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database.

4. Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.

5. Submits expeditable safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement, including electronic submission to database.

6. If SAEs are reported from blinded trials, the DSA assures maintenance of blinded treatment code, specifically when involved in the unblinding for regulatory reporting purposes.

7. Generates data listings from the safety database and assumes responsibility for accuracy of the data.

8. Supports the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.

9. Supports interim data analysis for DMC reviews.

10. Receives inquiries via phone, fax or email from consumers or healthcare professionals in support of marketed products; triages the inquiry as a request for medical information, product quality compliant and/or adverse event and processes received information in accordance with project specific instructions.

11. Properly documents all internal and external contacts and communications (e.g. with reporters of cases, sites, or clients whether verbal or written).

12. Ensures personal career goals are set each year and progress is monitored for completion.

要求：

本科及以上，生命科学相关专业，药学或临床专业；

熟练使用word, excel等软件；

英语听说良好，读写熟练；

应届毕业生或有1年左右相关工作经验，了解或熟悉药物警戒/药物安全相关工作内容；

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。