埃森哲信息技术（大连）有限公司（医疗外包项目主管）

O　Responsible　for　the　all　English　case　management　related　tasks
O　Would　assist　in　English　case　assessment，provide　training　for　the　team，and　manage　their　works.
O　Ensure　consistency　with　quality，accuracy，and　medical　safety　standards.
O　Work　to　ensure　documents　are　of　high　quality，scientifically　accurate，meet　company　standards　and　regulatory　requirements（e. G. ，SOPs　ICH　and　MHLW　guidance）and　reflect　a　consensus　among　team　members　that　is　acceptable　to　all　appropriate　reviewers
O　Communicate　with　client　if　it　is　required　during　the　Japanese　case　handling　processing
O　Track　AE　progress，and　alert　China　team　when　overdue

职位要求（必须有医药相关工作或教育背景）：
O　Good　experience　in　PV　or　closely　related　areas.
O　Experience　with　safety　document　writing.
O　Experience　of　reporting　AEs
O　Knowledge　of　Medical　terminology
O　Knowledge　of　ICH　regulatory　requirements　preferred
O　Knowledge　of　MedDRA（E）/WHODD　dictionaries　preferred.
O　Ability　to　prioritize　and　handle　several　tasks　simultaneously
O　Good　negotiation　and　oral　communication　skills.
O　Good　organization　management　skills

语言要求：

日语听说读写熟练（尤其日语医药术语）。英语能够读写优先考虑。