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周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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1年经验 -
本科 -
招若干人 -
11-09 发布
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 improvement3) Help works related to Quality Assurance (20%): collaboration with other functions and vendorsMajor Responsibilities and Duties:PV role (80%)1) Process Adverse Event case as per company procedures2) Submit safety reports to health authorities and license partners with right format and within right timeframes3) Help revise safety parts of study-related documents (protocol, ICF, IB etc.) under the supervision of PV head4) 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 minutes2) Oversee the progress of quality projects and goals for each department3) May help handle Quality non-compliance issues, keep Quality Issue Reports and maintain Corrective Action and Preventative Action(CAPA) listQualifications:1) Pharmacy or medicine education background, master degree preferred2) At least 1-2 year PV working experience in multinational pharmaceutical company, familiar with safety case processing in Argus or Arisg database3) Strong communication and coordination skills, ability to manage projects and learn new knowledge quickly4) 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
联系方式
金科路4560号金创大厦1号楼4楼
公司信息
ZAI Lab is a leading biotech company based in China focused on discovering and developing innovative medicines for unmet medical needs globally. The company is building a strong portfolio of therapeutic programs aimed at transforming patients’ lives. Zai Lab has a world class leadership team with deep experience at global pharmaceutical and biotech organizations. The team has a strong track record of success – successfully taken five novel drug candidates into clinical trials in China, pioneered new regulatory channels, secured regulatory approvals in record times, conducted multiple IND trials in the US, and brought the first China discovered drug into Global Phase III trials. Zai Lab is committed to build a globally leading drug research and development powerhouse with a culture of excellence and teamwork and a strong focus on fostering innovation and creativity. For more information, please visit www.zailaboratory.com.
