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工作地点: 浦东新区 招聘人数: 1人 工作性质: 全职
工作经验: 1年以上 学历要求: 本科 年龄要求: 不限
性别要求: 不限 薪资待遇: 面议 更新日期: 2020-07-07

岗位职责:

    1.Receive, track, process, and report SAE and AEs of Special Interest cases from clinical trials, within the required timeframe for regulatory reporting and data exchanging with HMP’s partners;
    2.Perform the case assessment for completeness, accuracy and legibility; Interpret source documents including relevant medical conditions, lab results and procedures to compile complete and accurate narrative summaries;
    3.Produce or review the clinical safety queries as needed for case clarification;
    4.Prepare safety periodic reports, e.g. Safety line listings, safety summary, with the required timeline;
    5.Interact on a regular basis with contract drug safety vendor (CRO safety team) to resolve safety-related issues in case processing;
    6.Be involved in case medical review for seriousness, expectedness, and causality;
    7.Be involved in generating and distributing the Safety Notification Letters of SUSARs, Clinical or Pre-clinical Safety Findings;
    8.Serve as a Safety Liaison Contact to other functions in clinical development for the assigned clinical projects;
    9.Complete the assignments in clinical projects, e.g. Review of safety management plans, safety sections of clinical protocols and CSRs, and others;
    10.Others, e.g. SOPs drafting, reviewing and maintenance.

职位要求:

    1.A bachelor degree or above, in medicine ( highly preferred), public health, nursing or other health disciplines;
    2.1-2 years working experience in pharmacovigilance, clinical research, or medical affairs;
    3.Knowledge of ICH/FDA/EMA/CFDA regulations/guidance for pharmacovigilance, and be familiar with GCP;
    4.Fluent in both written and spoken English;
    5.Good communication skills and computer skills.
联系方式
  • 联系电话:
  • 公司地址:上海市浦东新区张江高科技园区蔡伦路720弄4号楼
  • 公司官网:http://www.hmplglobal.com