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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmacovigilance-medical-safety-writing-course/
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课程名称：药物警戒医疗安全写作课程 课程概述：药物警戒医疗安全写作是药物开发、审批和上市后阶段中最重要的过程。这一过程需要高技能的人才，清晰理解法规和准则，因为报告必须非常准确并按时提交。药物警戒医疗安全写作者是药物警戒行业内需求最旺盛的专业人员，主要职责包括：撰写定期安全总结报告，收集和分析数据，准备列举表，总结制表，撰写安全评估，并检查格式和内容符合监管标准。 课程模块包括： 1. 介绍 2. 药物警戒文件的类型 3. 临市前：DSUR（药物安全更新报告） 4. 市场授权阶段：SCS（安全性与疗效总结）、ISS（上市后安全性报告）、风险评估与管理文件、120天安全更新报告 5. 授权后：PBRER（周期性利益风险评估报告）、PADER（药物不良事件报告）、临时安全审查、ACO（分析与评论意见）、PSUR附录、总结桥接报告 6. 准备文件的团队 7. 案例研究 培训认可与接受： - 世界卫生组织药物警戒指南 - 国际协调会议 - 良好药物警戒实践模块 职业机会： 1. 初入职场者可作为药物安全助理或药物安全医师，如果是生命科学毕业生或医疗卫生专业人员，药物安全助理的角色主要限于个案安全报告处理。 2. 三年经验可进入信号管理或汇总写作/药物警戒医疗安全写作团队。 3. 药物警戒流程中通常会有两个角色，一个针对其他医疗卫生专业人员，一般医师。 4. 通过药物警戒认证并有五年以上经验者可申请管理职位。 5. 还有其他角色，如质量保证和质量控制团队，以及药物警戒数据库管理员，基于个人兴趣和经验可选择相应职位。
About Course:Pharmacovigilance medical safety writing is most important process in every stage of drug development, approval and post marketing phase. This process require highly skilled people with clear understanding of regulation and guidelines as the reports should be very accurate and should be submitted as per timelines. PV medical safety writers are the most demanding professionals in PV sector due to the requirements from the authorities.Main responsibilities of PV medical safety writers:Writing periodic safety summary reports including collection, analyzing, preparing line listings, summary tabulations, drafting safety evaluationsChecking the format and content as per regulatory standardsCourse Modules:IntroductionTypes of Pharmacovigilance documentsPre-market: DSURMarketing Authorization phase: SCS, ISS, Risk evaluation and management documents, 120 day safety update reportsPost Authorization: PBRERs, PADERs, ADHOC safety review, ACO, PSUR addendum, Summary Bridging reports.Teams involved in preparing the documentsSample case studyTRAINING RECOGNITION & ACCEPTANCEWHO Pharmacovigilance GuidelinesInternational Conference on HarmonizationGood Pharmacovigilance Practices ModulesCareer opportunities: 1. As a fresher one can start their career in pharmacovigilance as drug safety associate/drug safety physician if you are a life science graduate or HCP. The role of Drug safety associates is mainly limited to ICSR processing. 2. With three years of experience you can be a part of signal management or aggregate writing/ PV medical safety writing teams. 3. For any team in pharmacovigilance process there will be two roles will be there one for other HCPs and one for Physicians. 4. With certification in pharmacovigilance and 5+ years of experience one can apply for management roles. 5. There are also other roles like QA and quality control teams, database admin in pharmacovigilance, based on interest and experience one can choose these positions.
