长沙招聘

工作职责:

Primary Responsibilities:

1.对研究者报告的不良事件进行分析和处理

2.对不良事件的名称，正确性，严重程度，发生情况，持续时间等相关信息进行审核，评价

3.审核不良事件的标准并根据对应的流程进行处理

4.撰写并编辑不良事件的发展经过

5.对于不良事件的后续发展进行跟踪

6.负责其他安全数据采集人或安全数据一致性核查人的沟通与联系

7.负责根据地方要求产生安全性数据报告

Carryout case processing activities

Review,rank, verify, process and document case-related information: event terms;validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments

Review case criteria to determine appropriate workflow for case processing

Assess cases to distinguish those with particular complexities and/or specific issues,and escalate appropriately

Write and edit case narrative

Determine and perform appropriate case follow-up, including generation of follow-up requests

Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation

Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database

Determine report ability of scheduled reports , ensuring adherence to regulatory requirements

任职资格:

Requirements

1.医学，药学，生物学等相关背景，本科及以上学历

2.有临床试验经验或者经过临床试验全过程培训，熟悉GCP优先

3.英语、日语读写流利

Experience in pharma covigilance and/or data management preferred but not required

Experience and skill with medical writing an advantage

Demonstrated computer literacy

Experience in use and management of relational databases preferred

Health Care Professional or equivalent experience preferred

Ability,with supervision, to solve routine problems and to surface issues constructively

Ability to make basic decisions with an understanding of the consequences

Ability to achieve personal objectives while meeting departmental standards of performance

Ability to work under supervision in a matrix organization

Fluency in spoken and written English and Japanese

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。