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

上班地址：东湖开发区高新大道666号