Clinical Project Assistant (PV/QA)
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：2016-11-16
- 工作地点：上海-浦东新区
- 招聘人数：1人
- 工作经验：1年经验
- 学历要求：本科
- 职位月薪：6000-12000/月
- 职位类别：临床研究员 质量管理/测试工程师(QA/QC工程师)
职位描述
职位描述：
Primary Function：
1. Help process Individual Case of Safety Reports(ICSRs) from clinical trials per company procedures and China PV regulations (60%)
2. Support PV& Quality Assurance (QA) head to perform QA-related tasks （40%）
Major Responsibilities and Duties:
PV work
1. Assist to process Adverse Event case as per company procedures after receiving relevant training
2. Submit safety reports to health authorities and license partners with right format and within right timeframes
3. Support other PV work: PV database setup, PV agreement with license partners, PV training, etc.
QA work
1. Help edit Quality-related documents (manuals, policies, SOPs, quality agreements) under the leadership of QA head
2. Coordinate relevant trainings and meetings, maintain meeting minutes
3. Oversee the progress of quality projects and goals for each department
4. Help handle Quality non-compliance issues, keep Quality Issue Reports
5. Manage list of Corrective Action and Preventative Actions(CAPA) and follow up with CAPA owner until completion
Qualifications:
1. Pharmacy or medicine education background, master degree preferred
2. Good in English reading and writing; master Microsoft Office software
3. Preferably with some working experience in pharmaceutical company
4. Strong communication and coordination skills, ability to manage projects and learn new knowledge quickly
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Primary Function：
1. Help process Individual Case of Safety Reports(ICSRs) from clinical trials per company procedures and China PV regulations (60%)
2. Support PV& Quality Assurance (QA) head to perform QA-related tasks （40%）
Major Responsibilities and Duties:
PV work
1. Assist to process Adverse Event case as per company procedures after receiving relevant training
2. Submit safety reports to health authorities and license partners with right format and within right timeframes
3. Support other PV work: PV database setup, PV agreement with license partners, PV training, etc.
QA work
1. Help edit Quality-related documents (manuals, policies, SOPs, quality agreements) under the leadership of QA head
2. Coordinate relevant trainings and meetings, maintain meeting minutes
3. Oversee the progress of quality projects and goals for each department
4. Help handle Quality non-compliance issues, keep Quality Issue Reports
5. Manage list of Corrective Action and Preventative Actions(CAPA) and follow up with CAPA owner until completion
Qualifications:
1. Pharmacy or medicine education background, master degree preferred
2. Good in English reading and writing; master Microsoft Office software
3. Preferably with some working experience in pharmaceutical company
4. Strong communication and coordination skills, ability to manage projects and learn new knowledge quickly
职能类别： 临床研究员 质量管理/测试工程师(QA/QC工程师)
关键字： PV, QA, 质量保证, 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