Mastering Pharmacovigilance Agreements

所在平台: Udemy

课程主页: https://www.udemy.com/course/mastering-pharmacovigilance-agreements-a-practical-guide/

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课程简介

**课程名称:** 熟练掌握药物警戒协议 (Mastering Pharmacovigilance Agreements) **课程概述:** 本课程专为药学学生、医学从业者以及生命科学专业毕业生设计。它将帮助您深入理解药物警戒协议 (PVA) 领域,特别是对于已经拥有个人安全性报告 (ICSR)、汇总报告、信号管理或风险管理经验的专业人士,以及希望在药物警戒协议领域学习和发展职业生涯的人士。药物警戒协议属于“利基技能”,市场需求高但人才资源相对稀缺,因此它在药物警戒/制药领域是一个高薪且具有挑战性的职业。 本课程的培训师拥有超过11年的跨国制药公司药物警戒行业经验,在ICSR、汇总报告、信号和风险管理方面拥有丰富的专业知识。 **课程涵盖的主要内容:** * 药物警戒协议的重要性 * 药物警戒协议的基本要素 * 药物警戒协议的生命周期 * 药物警戒协议的类型 * 在药物警戒管理系统 (PSMF) 中的PV协议 * 安全性数据交换协议 * 药物警戒协议的不同阶段: * 起草新PVA * PVA更新 * PVA修正 * PVA终止 * PVA的最终确定和执行 * PVA跟踪 * 监控PVA合规性 **学习成果:** 完成本课程后,您将能更自信地应对药物警戒协议相关的面试,并学习到药物警戒新领域方面的知识。 **目标学员:** * 药学学生 * 医学从业者 * 生命科学专业毕业生 * 具有ICSR、聚合报告、信号管理或风险管理经验的药物警戒领域专业人士 * 希望在药物警戒协议领域提升职业生涯的专业人士

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课程详情

This course is exclusively designed for Pharma students, Medical practitioners and Life science graduates. This course will be helpful to those who have ICSR, Aggregate Reporting, Signal management or Risk management experience in Pharmacovigilance domain and for those who wants to learn and excel their career in Pharmacovigilance Agreement (PVA). This Job role (Pharmacovigilance Agreement) comes under Niche Skill, which means there is high demand and less resources available in the industry. This is one of the high paying Job Role in Pharmacovigilance/ Pharma domain. Pharmacovigilance Agreement is complex but challenging role in Pharmacovigilance domain.The Trainer of this course has more than 11 years of Pharmacovigilance Industry Experience from different multinational companies (MNC). He has expertise in ICSR, Aggregate Reports, Signal and Risk Management.In this course we have covered following topics:Importance of Pharmacovigilance AgreementsEssential Elements of Pharmacovigilance AgreementLife-Cycle of Pharmacovigilance AgreementsTypes of Pharmacovigilance AgreementsPV Agreements in PSMFSafety Data Exchange AgreementDifferent Phases of Pharmacovigilance Agreements:- Drafting new PVA- PVA Update- PVA Amendment- PVA Termination- PVA Finalization and Execution- PVA Tracking- Monitoring PVA complianceBy completing this course, you will be more confident to face your interview in Pharmacovigilance Agreement. You will learn new aspects of pharmacovigilance areas. Thanks.Good Luck!!!

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