|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/job-oriented-certificate-course-in-pharmacovigilance/
课程评论：没有评论
**课程名称：** 全球药物警戒证书课程 **课程概述：** 本证书课程专为药学、医学和生命科学专业的学生、医生及毕业生设计。该课程为初学者提供了一个独特的学习平台，帮助其掌握药物警戒（PV）的基础和中级概念。对于近期刚接触药物警戒领域的专业人士，本课程同样极具价值。 在印度，药物警戒从业者的起薪范围为每年 2.5 万至 5 万卢比。本课程的讲师拥有超过十年的跨国制药公司药物警戒行业经验，在个体安全性报告（ICSR）、汇总报告、信号识别和风险管理方面具有丰富的专业知识。 **课程内容亮点：** * **药物警戒入门：** 涵盖药物警戒的定义、发展历史、核心目标。 * **安全性事件解析：** 深入理解不良事件（AE）、药物不良反应（ADR）及副作用，事件严重性的评估，以及因果关系评估。 * **报告和提交：** 学习标签要求、病例有效性最低标准、病例分类、病例报告撰写，以及向监管机构提交病例的规定时间。 * **关键概念：** 掌握停药/再用药（Dechallenge/Rechallenge）概念，ICSR 的主要来源，以及上市后安全性失性事件（SUSAR）的重要性。 * **医疗术语：** 基础的医学词典（MedDRA）和世界卫生组织药品字典（WHO Drug Dictionary）知识。 * **监管环境：** 介绍重要的监管机构。 * **实践操作：** 演示安全性数据库的实际操作，以及如何解读源文件。 * **职业发展指导：** 提供额外的指导课程，包括如何准备药物警戒面试、如何寻找药物警戒工作，以及为何药物警戒是极佳的职业选择。 **学习收获：** 完成本课程后，您将对药物警戒领域有全面而深入的理解，并能更有信心地应对相关的面试。课程提供的实践操作和职业发展指导，将有力地助您实现进入药物警戒领域的职业梦想。祝您好运！
This course Certificate Course in Global Pharmacovigilance is designed for Pharma students, Doctors and Life science graduates. This is a unique course for Fresher's which can help them to understand Basics and Intermediate level of Pharmacovigilance (PV) concepts. This course will also be helpful to those who have early stage experience in Pharmacovigilance.The salary for Pharmacovigilance professional in India for fresher's ranges between 2.5 Lakhs to 5.0 Lakhs.The trainer of this course have more than 10 years of Pharmacovigilance Industry Experience from different multinational companies. He has expertise in ICSR, Aggregate Reports, Signal and Risk Management.In this course we have covered following topics:Introduction of this courseWhat is PharmacovigilanceHistory of PharmacovigilanceObjectives of PharmacovigilanceAE, ADR and Side EffectsEvent seriousnessCausality AssessmentLabellingMinimum criteria for case validityCase triageCase NarrativeCase submission timelines to regulatory authorityDechallenge/ Rechallenge conceptSources of ICSRSUSAR and Its ImportanceSpecial situation scenariosBasics of MedDRABasics of WHO Drug DictionaryImportant regulatory AuthoritiesHow source document looks likePractical Demo of Safety DatabaseAdditional Guidance SessionsHow to prepare for PV Interview?How to find PV Job?Why PV is the best career choice?By completing this course, you will be more confident to face your interviews.Along with main course, we have also shared Practical demo of Safety database and Additional Guidance sessions on How to find Pharmacovigilance Job, How to prepare for Pharmacovigilance Interview and Why Pharmacovigilance is the best career choice.We hope you will find this course very helpful and you will land your dream job in PV very soon. Good Luck!!!
