长沙招聘

  

The Drug Safety Physician/Scientist is responsible for monitoring and management of safety profile for the assigned projects and drugs.

  

RESPONSIBILITIES Proactively review and evaluate the clinical implications of safety data from different sources for assigned projects; Conduct signal detection and evaluation for assigned projects; Review and input on protocols, IBs and all safety sections of clinical and/or regulatory submission documents; Draft, review Periodic Safety Report (e.g., DSUR and PSUR); Draft, review the safety part of Investigator Brochure Draft SUSAR notification letter;

  

Provide responsible development projects with safety input and support; Implement other safety responsibilities assigned by LM

  EXPERIENCE Required Skills and Knowledge: Minimum 3 years of Drug Development/Drug Safety experience Good knowledge of medical terminology Good written and communication skill Working knowledge of MedDRA and WHODrug dictionary In-depth knowledge in drug safety regulations and policies Fluent in Chinese (spoken and written) and in English (written) Computer literacy Desired Skills: Experience in pharmaceutical safety-related role Requirements

PPC佳生集团（PPC Group）是一家成立于1997年的临床CRO公司。总部设立于上海，并分别在台北，徐州，北京，南京，首尔及东京设立了分部及分公司。
     自成立以来我们始终致力于为国内外制药企业及生物技术公司提供专业的临床研究服务及生物样本分析服务。至今，PPC佳生已经完成了超过3000项早期临床试验项目及超过500项II期至IV期临床试验项目，其中涉及24个主要研究领域。
     另外，PPC佳生的I期临床中心及生物分析实验室也分别通过了美国FDA,中国NMPA,台湾TFDA,日本PMDA,欧盟EMA及马来西亚NPRA等的核查。
     2012年，PPC佳生在台北（MacKay Memorial Hospital）建立了***家专属I期临床研究中心；2017年初与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心；2018年，PPC佳生又分别与徐州市中心医院，湖北省鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。截至目前，PPC佳生已有5家自主运营的I期临床中心。