医学监查员 北京

月薪： 1-1.5万/月

该公司所有职位
  • 无工作经验
  • 硕士
  • 招2人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 通讯补贴
  • 餐饮补贴
  • 交通补贴
  • 绩效奖金
  • 年终奖金

职位描述

职位描述： Responsibilities: 工作职责：1.Proactively provide the medical leadership and scientific input to improve the project quality in the function of medical science, phamacovigilance, clinical operation and data management etc.在医学/科学事务，临床研究运营，药物警戒和数据管理等多项职能工作中，主动提供医学专业领导力和科学指导，提高临床试验质量。2.In the area of medical science and clinical operation , MM should try to cover the following activities:在医学/科学事务和临床研究营运中，医学监查员需要参与以下工作：    1)Clinical and scientific expertise to the clinical trial protocol development process    在研究方案制定中提供临床和科学专业知识    2)MMP/SMP development    参与制定医学监查计划和安全管理计划    3)Medical support for monitoring guidelines, statistical analysis plans, informed consent documents,clinical review forms, data edit checks, data quality planning    对于监查指南、统计分析计划、知情同意书、病历报告表、数据核查、数据质量计划给予医学支持    4)Medical assessment of subject eligibility    对于研究中受试者的合格性进行医学评估    5)Review of protocol deviations & conduction consistency in medical compliance of the protocol    审核方案违反和操作一致性，以确保方案在医学方面的依从性    6)Medical training of TA, protocol and other medical relative topics     提供治疗领域、方案和其他医学相关内容的医学培训3.In the area of pharmacovigilance and data management, MM should try to cover the following activities:在药物警戒和数据管理中，医学监查员需要参与以下工作：   1)Responsible for medical review of serious adverse events and non-serious adverse events from spontaneous reports and reports derived from regulatory authorities and the medical literature during post-marketing surveillance in support of drug safety activities for clients.    负责对自发报告和源自监管当局的报告中的严重不良事件及非严重不良事件进行医学审核，并且对上市后监督过程中支持客户进行药物安全活动的医学文献进行医学审核。    2)Medical review of assigned cases .    指定案例的医学审核。   3)Perform weekly review of non-serious line listings for potential upgrades to serious and provide medical guidance to triage staff.    每周审核非严重案例列表，查看其是否有升级至严重案例的可能，为分流人员提供医学指导。    4)Write medical query and similar event analysis and provide causality assessment for individual case.    书写医学疑问和类似事件分析，提供个别案例的因果关系评估。    5)Review of aggregated reports .    根据产品安全概况审核汇总报告。   6)Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within the organization or/and client.对临床试验或上市后产生的安全问题提供评估，并且将这些安全问题递交给组织内的部门经理和客户。   7)Review and use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project.审核并且使用临床试验方案，产品信息，公司核心数据表和在指定项目中需要的任何其他产品相关信息。    8)Review and provide input to the Project Specific Procedures and participate in project related meetings.    审核并输入到项目具体程序中，参加项目相关会议。    9)Communicate with the client to an extent as described in the Project Specific Procedures.    如项目具体程序中描述的那样在某种程度上与客户沟通。    10) Provide assistance in the preparation and conduct of medical coding convention.    在医学编码约定的准备和实施过程中提供帮助。    11) Potentially, provide support to the Drug Information & Pharmacovigilance Product Support (call) Centre and the related projects, including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions    可能为药物信息和药物警戒产品支持中心（电话）及相关项目提供支持，包括向来访者提供产品相关信息，并审核和评估已报告的不良反应。     12) Involve in the SAE reconciliation between the clinical database and the safety database     参与SAE在临床数据库和安全数据库的核对     13) Lead the DMC review and signal detection analysis     负责协调数据检查委员会审核和信号检测分析Qualifications任职资格(a) Medical background, a master degree of clinical medicine in a certain therapeutic area临床医学硕士（擅长某一治疗领域如心血管）(b ) At least 2-year experience of clinical practice in the hospital (the experience of medical affairs in the pharmaceuticals is preferred)至少2年医院临床实践经验 （有药厂医学事务经验者优先考虑）(c) Familiar with the knowledge of the clinical practice in one therapeutical area at least, GCP and the SOP of clinical study熟悉至少一个治疗领域临床应用知识，GCP，临床试验操作标准流程。(d) Fluent in written and verbal English流利掌握英语口语和书面英语 职能类别： 临床研究员 关键字： 医学监查 医学科学事务 安全管理 药物警戒 数据管理

联系方式

北京市朝阳区东四环中路78号大成国际中心A2座0310室

公司信息

北京翰博瑞强医药信息咨询有限公司(H&J CRO International, Inc.)成立于2003年，致力于全球医药研发的创新外包组织（Contract Research Organization, CRO）。H&J总部位于享有"全球医药研发之都"美誉的美国新泽西州(New Jersey)，中国总部位于上海，同时在北京、广州、武汉、成都等15个核心城市设有分支机构，现拥有员工近400人。

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