五百强药企Patient Safety Associate
北京外企德科人力资源服务上海有限公司
- 公司规模:10000人以上
- 公司性质:合资(欧美)
- 公司行业:专业服务(咨询、人力资源、财会)
职位信息
- 发布日期:2019-11-17
- 工作地点:北京-朝阳区
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:招1人
- 语言要求:不限
- 职位月薪:1-1.5万/月
- 职位类别:临床数据分析员
职位描述
1. Product safety surveillance
· Handling of all local safety information, including collection, registration, translation from local language into English, and transmission to GPS as applicable in a timely manner
· Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner
· Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements
· Performing screening of relevant local health authority web sites according to global standards as defined by relevant quality documents
· Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed
· Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling
· Performing required safety activities in the absence of the LPSO
2. Reporting to local Health Authorities and Ethics Committees
· Timely submission of expedited ICSRs to concerned local health authorities (where applicable)
· Support of e-reporting in e-reporting ready countries (where applicable)
· Timely submission of expedited cases to concerned local/central EC/IRBs as applicable
· Timely submission of safety issue reports to concerned local health authorities
· Timely submission of safety issue reports to concerned local/central EC/IRBs as applicable
3. Compliance related activities
· Using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines
· Supporting the LPSO to ensure compliance reports to GPS via the applicable technical tool (e.g. SCCT) in a timely manner
· Contributions to the Local PV file in close collaboration with cross-functions to support completeness, accuracy and that relevant information is updated in a timely manner
4. Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries
· Supporting the LPSO that a complete overview on local / global clinical studies and PDCS (planned as well as ongoing) in the local affiliate is kept
· Supporting the LPSO that current global procedures for the handling of PDCS and clinical studies are followed
职能类别:临床数据分析员
公司介绍
成立于1979年,FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质,是中国人力资源服务行业的领跑者,Adecco则是全球人力资源行业的巨头,服务网络遍布全球60多个国家和地区。FESCO Adecco成立后,双方通过优势互补,整合了客户资源,依托全球化的资源和服务平台,融合本土网络优势,扩大了业务范围,为客户提供全方位的业务流程外包(BPO)、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展,并且在浙江、重庆、深圳、苏州设立了分支机构。目前,FESCO Adecco在中国每天服务达100万名员工,服务客户近12,000家。
FESCO Adecco致力于成为***的人力资源全面解决方案提供商,成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门,推动中国乃至全球的人力资源外包产业的健康发展。
联系方式
- Email:recruitment@circassia.com
- 公司地址:天目西路128号嘉里不夜城企业中心***座19楼