PV Specialist
再鼎医药（上海）有限公司
- 公司规模：500-1000人
- 公司性质：外资（非欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-11-30
- 工作地点：上海-浦东新区
- 工作经验：1年经验
- 学历要求：本科
- 职位月薪：0.7-1万/月
- 职位类别：医药技术研发人员 生物工程/生物制药
职位描述
职位描述：
Primary Function:
1) Handle Adverse Event(AE) reports as per company procedures and China PV regulations (50%)
2) Help other work related to PV (30%): PV training, PV agreement execution, PV procedural documents improvement
3) Help works related to Quality Assurance (20%): collaboration with other functions and vendors
Major Responsibilities and Duties:
PV role (80%)
1) Process Adverse Event case as per company procedures
2) Submit safety reports to health authorities and license partners with right format and within right timeframes
3) Help revise safety parts of study-related documents (protocol, ICF, IB etc.) under the supervision of PV head
4) Support other PV work: PV database setup, PV agreement with license partners, PV training, etc.
QA role (20%)
1) Coordinate relevant training and meeting, maintain meeting minutes
2) Oversee the progress of quality projects and goals for each department
3) May help handle Quality non-compliance issues, keep Quality Issue Reports and maintain Corrective Action and Preventative Action(CAPA) list
Qualifications:
1) Pharmacy or medicine education background, master degree preferred
2) At least 1-2 year PV working experience in multinational pharmaceutical company, familiar with safety case processing in Argus or Arisg database
3) Strong communication and coordination skills, ability to manage projects and learn new knowledge quickly
4) Good in English reading and writing; master Microsoft Office software
Primary Function:
1) Handle Adverse Event(AE) reports as per company procedures and China PV regulations (50%)
2) Help other work related to PV (30%): PV training, PV agreement execution, PV procedural documents improvement
3) Help works related to Quality Assurance (20%): collaboration with other functions and vendors
Major Responsibilities and Duties:
PV role (80%)
1) Process Adverse Event case as per company procedures
2) Submit safety reports to health authorities and license partners with right format and within right timeframes
3) Help revise safety parts of study-related documents (protocol, ICF, IB etc.) under the supervision of PV head
4) Support other PV work: PV database setup, PV agreement with license partners, PV training, etc.
QA role (20%)
1) Coordinate relevant training and meeting, maintain meeting minutes
2) Oversee the progress of quality projects and goals for each department
3) May help handle Quality non-compliance issues, keep Quality Issue Reports and maintain Corrective Action and Preventative Action(CAPA) list
Qualifications:
1) Pharmacy or medicine education background, master degree preferred
2) At least 1-2 year PV working experience in multinational pharmaceutical company, familiar with safety case processing in Argus or Arisg database
3) Strong communication and coordination skills, ability to manage projects and learn new knowledge quickly
4) Good in English reading and writing; master Microsoft Office software
职能类别： 医药技术研发人员 生物工程/生物制药
关键字： PV, 药物安全
公司介绍
Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.
再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。
再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。
联系方式
- 公司地址：地址：span上海浦东张江高科技园区金科路4560号金创大厦3号楼8楼