PV manager I/II
百济神州(北京)生物科技有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-08-27
- 工作地点:北京
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:本科
- 职位类别:其他
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.
职位要求:
? 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)
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.
职位要求:
? 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)
职能类别:其他
公司介绍
百济神州是一家立足于科学的全球性生物科技公司,专注于开发创新、可负担的药物,旨在为全球患者改善治疗效果,提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作,加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。
联系方式
- Email:shan.liu@beigene.com
- 公司地址:昌平区生命科学园 (邮编:102206)