工作职责 Position Purpose - Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements. 审核，准备，完成药物不良经历报告，帮助认识辉瑞产品的安全面貌，并符合法规报告要求。 Primary Responsibilities - Provide professional evaluation to Individual Case Safety Report (ICSR) in Pfizer Safety Database, including but not limited the activities as follows. 在辉瑞安全数据库中，对ICSR做专业评估。 包括但不仅限于以下内容。 - Identify reportable cases, evaluate cases in appropriate prioritization, and meet reporting timeline 明确需要提交的报告，合理安排优先秩序对报告进行评估，符合报告时限。 - Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; and etc. 对下述内容进行审核，排序，核对，评估和存档：事件，报告类别（有效性，严重性，已知性），特殊情况，产品投诉信息，等等。 - Write and edit the case narrative. - Consistently apply regulatory requirements and Pfizer policies. 完全遵守法规要求和辉瑞政策。 任职资格 Technical Skill Requirements · Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement. 具有以下经验者优先考虑：药物警戒，临床实践，临床或科学性研究。 但不是必须。 · Demonstrated computer literacy, particularly in the use and management of relational databases. 熟练运用计算机，特别是有使用相关数据库经验者。 · Excellent oral and written communication skills. 良好的口头和书面沟通能力。 · Fluency in spoken and written English. 流利英语口语和书写。 Qualifications (i.e., preferred education, experience, attributes) · Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred. 科学相关领域本科及以上，药学，护理，或同等学历；医务工作资质者优先考虑。 · Ability, with supervision, to solve routine problems and to surface issues constructively. 能在指导下解决日常问题，并且建设性面对难题。 · Ability to make basic decisions with an understanding of the consequences. 能在理解事情结果的情况下独立做决定