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  1. 日语人才就业网
  2. 上海日语人才招聘信息
  3. Associate GSPV Medical Director

Associate GSPV Medical Director

需要确认/非公开

  • 盈帆达医药咨询(上海)有限公司
  • 工作地: 上海 上海市区
  • 日语水平:精通-较多商务交流经验 │工作年限:5-10年

全球Top 3 CRO公司

  • 正式员工
  • 5-10年
  • 结束刊登
发布时间:2017/11/22~2018/05/21

职务概要

职位种类 执行官/执行官
行业类别 医疗/ 医药品
职位类型 正式员工
岗位级别 部长/总监级别
招聘人数 1
希望入职时间 -
必须语言能力

日语 (精通-较多商务交流经验)

英语 (精通-较多商务交流经验)

汉语 (母语水平)

希望具备的语言能力 -
工作时间 全职
福利待遇和带薪休假 15天年假,15天带薪病假

详细工作内容

The position is responsible for providing safety management, medical oversight and assessment of pharmacovigilance activities as assigned.

 

Job Responsibilities:

 

  • Identifies, communicates and effectively manages potential safety issues
  • Works closely with pharmacovigilance colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
  • Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical safety information
  • Provides investigator support regarding safety concerns, medical emergencies, etc
  • Participates in medical safety surveillance/signal detection benefit/risk assessment, and development of trend analyses
  • Participates in development of REMS and RMP as required
  • Discusses and resolves medical issues with clinical sites, clients, and drug safety staff
  • Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
  • Consults with internal and external customers in the area of drug safety
  • Supports business development through participation in core proposal team activities, feasibility assessments and review of proposals/contracts for medical services
  • Maintains medical and pharmacovigilance expertise through appropriate CME
  • Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.


Job Qualifications:

 

  • English, Japanese is mandatory
  • The incumbent should possess M.D., B.M.B.S., D.O. or equivalent degree from an accredited medical school
  • Minimum one year of experience in the pharmaceutical, biotechnology or device industry working in pharmacovigilance/epidemiology
  • Knowledge of global pharmacovigilance regulations and processes
  • Computer proficient
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

 

Company description

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

 

关于面试

联络人

中国上海上海市区上海市南京西路688号506室 地图



招聘负责人姓名:jiajie gu

Associate GSPV Medical Director

盈帆达医药咨询(上海)有限公司

需要确认/非公开

结束刊登

公司简介

盈帆达医药咨询(上海)有限公司Associate GSPV Medical Director 盈帆达医药咨询(上海)有限公司Associate GSPV Medical Director

盈帆达医药咨询(上海)有限公司

医疗 /医药品

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

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