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    2022.04.01 发布
    全球药品安全临床数据管理专员(JPV)
    9-10K 查看薪酬>
    • 北京
    • 本科
    • 应届毕业生
    • 2人
    • 性别不限
    • 收藏
    源网站申请
    职位描述:

    Brief Description of Position:


    The Safety Data Specialist (JPV)(SDS JPV) is responsible for processing adverse events (AE) information in the global safety system for investigational and/or marketed products, under the direction and supervision of a GPVCM Manager. The SDS performs triage, analysis and interpretation of AE data following our Company Standard Operating Procedures (SOPs) and guidelines. The SDS should understand the importance of high quality and compliant AE case management. The SDS should also have a clear perception of case management processes, adhere to corporate policies and follow the company’s Ways of Working, including leadership behaviors.



    Responsibilities and Primary Activities (may include but are not limited to):


    - Through daily case prioritization activities, ensures completion of reports within the established internal, business partner and regulatory agency timelines.

    - Ensures quality and consistency with guidelines.

    - Performs case translation and/or submission in compliance with requirements of worldwide regulatory agencies.

    - Clarifies discrepancies in the incoming information to achieve unequivocal text in a standardized form.

    - Effectively communicates with internal and external stakeholders on any inquiry or request.

    - Exchanges communication with Business Partners (BPs) following agreements, to ensure compliance with internal, BP and worldwide regulatory agency reporting requirements.

    - Successfully completes training and independence assessment activities for GPVCM JPV specialists.



    Education and other Qualifications:


    ü Bachelor’s degree, preferably in Health Care or role related disciplines

    ü Advanced writing/reading and intermediate speaking/listening Japanese & English language skills

    ü Basic IT skills (Outlook, Excel, browsing tools)



    Levels required for Core Competences (Classifications of the levels from the lowest to the highest: Learning, Applying, Advanced and Expert)

    · Professional Competencies

    o Working Across Boundaries (Learning).

    o Strategic Thinking (Learning).

    o Project Management (Learning).

    o Productive Communication (Learning).

    o Problem Solving (Learning).

    · Core Functional Competencies

    o Data Analysis, Interpretation & Communication (Learning).

    o Competitive Decision Making & execution (Learning).

    o Collaboration & Partnering (Learning).

    o Business & Operations Management (Learning).

    o Regulatory & Compliance Management (Learning).

    o Disease Area Knowledge (Sub Competencies) (Learning).


    职位来源:
    以上内容仅为本站快照,最新信息请查看源网站
    最近更新: 2022.04.01
    来源网站:
    公司简介:
    默沙东

    今天的默沙东正致力于为全世界带来健康的福音。我们为全球140多个国家提供药物、疫苗、生物制剂、健康消费品和动物保健产品,并与客户一起提供创新的健康解决方案。同时,我们还致力于通过各种意义深远的项目向需

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    北京管理

    23544 /月

    来自最近一年83798份样本数据

    学历占比: 本科 40%

    工作经验占比: 1年以上 100%

    104.2%

    北京地区

    平均工资比

    245.4%

    全国地区

    平均工资比

    数据源于找工易用户,更新于2022-4-09

    公司平均工资,取自该公司更新时间一年内员工发布的工资信息,仅供参考。

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