The China Drug Safety Associate is responsible for safety data management, PV system management.

This role should understand company’s code of conducts & compliances policies & China & global PV Regulations, and to manage the daily PV activity to align with these accordingly.

• Ensure all AE are collected through PV maintained channels, including but not limited to PV Mailbox, PV website, fax, Literature, etc. to ensure spontaneous AE can be reported to sponsor any time.

• Manage the PV ICSR reporting and submission activities including: Individual AE report handling, CFDA batch case handling, Internal/vendor case QC, etc; to ensure the quality and compliance.

• Manage the PV periodic safety reporting activities including, Foreign ADR Line Listing submission, Study SUSAR Line Listing, PSUR/PBRER submission; to ensure the quality and compliance.

• Distribute safety information to study management team

• Maintain product list, ISL, KUR, SSI

and any China specific PV system to support ICSR or period reporting handling and submission.

• Be back up for team members.

• Monthly AE reconciliation with cross functional team which has interaction on AE reporting.

• Implement of Licensing Agreements.

Job requirements 工 作 要 求

- Academic / Professional qualification 学 历 / 专 业 资 格

• Bachelor degree in medical or pharmaceutical sciences required

- Technical / skills training 技 术 / 技 能 训 练

• China Regulations on Safety Reporting

• ICH Guideline.

• Knowledge in clinical development, GCP

- Working experience

( no. of years 年 资 job function 工 作 功 能 business types 业 务 种 类 )

Essential 必 需

• 0-1 year working experience on pharmacovigilance area in pharmaceutical company

Desirable 理 想

• Multinational pharmaceutical company working experience

- Language ability 语 言 能 力

• Fluent Mandarin and English in reading and writing

- Computer literacy 电 脑 知 识

• Familiar with word-processing software, Excel, Powerpoint, etc.

- Others 其 他

• Good knowledge of diseases and drugs

• Project management