PV Physician
苏州艾博生物科技有限公司
- 公司规模：150-500人
- 公司性质：合资
- 公司行业：制药/生物工程
职位信息
- 发布日期：2022-06-26
- 工作地点：北京-朝阳区
- 工作经验：5-7年经验
- 学历要求：硕士
- 职位月薪：2.5-5万
- 职位类别：药物警戒经理
职位描述
职责描述：
1. Provide supports on clinical studies activities
· Ensure the proper and sufficient communication and implementation of regulatory requirement from different authority.
· Provide safety related support to clinical trial, support IND submission, NDA submission and Product Launch, in close collaboration with project team.
2. Provide supports on establishing and improvement of PV system
· Provide support to stablish and maintain the PV System in accordance with relevant regulation
· Provide support to prepare PV master file and medical safety relevant SOPs
· Provide support to maintain the PV database, monitor appropriate safety database workflows
3. Perform safety surveillance and provide safety supports on post marketing products
· Perform periodically safety data review on post marketing safety data to identify the potential signal with the product
· Contribute to aggregate report (e.g. PSUR) preparation and submission
任职要求：
1、experience in PV in the pharma industry over 5 years
2、Degree in health care or life sciences
3、Communicate and write English and Chinese documents with high-qualit
1. Provide supports on clinical studies activities
· Ensure the proper and sufficient communication and implementation of regulatory requirement from different authority.
· Provide safety related support to clinical trial, support IND submission, NDA submission and Product Launch, in close collaboration with project team.
2. Provide supports on establishing and improvement of PV system
· Provide support to stablish and maintain the PV System in accordance with relevant regulation
· Provide support to prepare PV master file and medical safety relevant SOPs
· Provide support to maintain the PV database, monitor appropriate safety database workflows
3. Perform safety surveillance and provide safety supports on post marketing products
· Perform periodically safety data review on post marketing safety data to identify the potential signal with the product
· Contribute to aggregate report (e.g. PSUR) preparation and submission
任职要求：
1、experience in PV in the pharma industry over 5 years
2、Degree in health care or life sciences
3、Communicate and write English and Chinese documents with high-qualit
公司介绍
苏州艾博生物科技有限公司成立于2019年初，是一家专注于信使核糖核酸（mRNA）药物研发的临床期创新型生物医药公司，拥有业界领先的具有自主知识产权的mRNA和纳米递送技术平台。公司已建立了丰富的产品管线，涵盖***防治和肿瘤免疫等领域。2020年6月，公司联合军事科学院军事医学研究院、沃森生物共同研制的新型冠状病毒mRNA疫苗，正式通过国家药品监督管理局临床试验批准，成为国内***获批开展临床试验的mRNA疫苗。目前该疫苗已完成I期、II期临床研究，目前处于临床III期阶段。