PV Manager
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:2019-10-11
- 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:招1人
- 语言要求:不限
- 职位类别:生物工程/生物制药
职位描述
Responsibilities
-Works with Drug Safety AP leadership team to communicate project status information; collaborate on project issue identification and resolution; and provide PV technical expertise where needed.
-Coordinating/supervising all PV tasks generated in clinical trials and other responsible projects, ensure these trials/projects are carried out according to the relevant quality documents and standards and regulatory requirements.
-Oversight compliance of regulator safety submission and distribution.
-Manage and support department internal and external communications between drug safety and other functions.
-Assist in the development of department-specific SOPs and Work Instructions.
-Support internal and external PV &DS department audits or inspections.
-Support BeiGene safety systems team (Argus and other supporting systems) to ensure the system running normally.
-Assist in the preparation of PV training material, act as a training resource to related personnel.
-Participate in other department projects as needed
职位要求:
Qualification
-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)
-Works with Drug Safety AP leadership team to communicate project status information; collaborate on project issue identification and resolution; and provide PV technical expertise where needed.
-Coordinating/supervising all PV tasks generated in clinical trials and other responsible projects, ensure these trials/projects are carried out according to the relevant quality documents and standards and regulatory requirements.
-Oversight compliance of regulator safety submission and distribution.
-Manage and support department internal and external communications between drug safety and other functions.
-Assist in the development of department-specific SOPs and Work Instructions.
-Support internal and external PV &DS department audits or inspections.
-Support BeiGene safety systems team (Argus and other supporting systems) to ensure the system running normally.
-Assist in the preparation of PV training material, act as a training resource to related personnel.
-Participate in other department projects as needed
职位要求:
Qualification
-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:生物工程/生物制药
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)