上海和誉生物医药科技有限公司

PV operation Manager

Shanghai, Shanghai, CN

7 months ago
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Summary

该职位来源于猎聘 职责描述: Responsible for the handling and reporting of ICSRs from Clinical Trial projects (Including but not limited to case processing, submission and distribution, cross reporting, and safety data exchange, etc.).

Develop and implement safety management plan of Pharmacovigilance department, performing regular reconciliation, maintaining line listings.

Provide support for PV related documents in clinical trials.

Responsible for organization/development/quality control/distribution and submission of development safety updated report. 任职要求: 1.

本科及以上学历。 2.

2-5年PV Operation相关工作经验,至少1年上市前PV Operation经验,熟练使用PV系统,有个例安全性报告处理的经验,有上市前临床试验项目PV管理的经验。 3.

较强的英语书面能力,英语口语顺畅者更佳。 4.

具有较强的学习能力和沟通能力。 5.

积极主动,富有责任心,执行能力强,具有较强的抗压能力。

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