• 招聘类型：社招
• 工作性质：全职
• 所属区域：北京 - CBD
• 直属部门：PV

职位描述

1. Ensure collection, processing and submitting of safety information from all source with BeiGene products according to company SOP and China regulatory requirement.

2. Manage and oversight the following activities (include but not limited) in accordance with company SOP and China regulatory requirement:

1) Non-international program management and oversight

2) Oversight literature, medical information, product quality complaint, media etc. for AE reporting

3) Post market study management and oversight

4) PV agreement management

5) Aggregate reports (PSUR/PBRER, annual report, foreign case line listing etc.) preparation and submission

6) Query response and safety issue management

3. Prepare PV training material, provide PV training to internal company staffs and external personnel.

4. Develop and review safety operation related SOP or working instruction to ensure alignment with company SOP and China regulation.

5. Manage and support department internal and external communications between drug safety and other functions.

6. Support safety inspection by health authority and audit by internal and external functions or business partners.

任职条件

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
• 4 years or more PV work experience in the Pharmaceutical or CRO industry, have a deep understanding of pharmacovigilance and regulatory requirements & processes.
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi task
• Fluent in English (writing and speaking)

职位要求

• 学历要求：本科
• 工作经验：4年以上
• 外语要求：不需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日