What you'll learn
Pharmacovigilance Signal Detection and Process flow
Steps of Signal Management
Role of Safety Governance Body
Format and Template of Signal Assessment Report
Definition and Signal terminology
Analysis of data from different sources
Requirements
Basic Level of English
Good quality of Internet connection
Desktop, Laptop or Smartphone
Description
This course is exclusively designed for Pharma students, Medical practitioners and Life science graduates. This course will be helpful to those who have ICSR and Aggregate Reporting experience in Pharmacovigilance domain and for those who wants to learn and excel their career in Pharmacovigilance Signal detection/ Management. This Job role (Signal detection expert) 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.The Trainer of this course has more than a decade 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:Introduction and purpose of this courseSignal terminologiesSignal Management process flowQualitative and Quantitative signal detectionRole of Safety Governance BodyAnalysis of different data sources (Pharmacovigilance database, Literature, Clinical and nonclinical studies, Medical textbooks, EVDAS, WHO VigiBase, FAERS)Format and Template of Signal Assessment ReportBy completing this course, you will be more confident to face your interview in Pharmacovigilance Signal detection/ Management. You will learn new aspects of pharmacovigilance signaling processes. We hope you will find this course very helpful, and you will land your dream job in Pharmacovigilance Signal detection/ Management very soon. Good Luck!!!
Overview
Section 1: General Information
Lecture 1 Topics to be covered
Lecture 2 Introduction & Purpose of this Course
Lecture 3 Signal Terminologies
Section 2: Process flow of Signal Management
Lecture 4 Signal Detection
Lecture 5 Signal Validation
Lecture 6 Signal Prioritisation
Lecture 7 Signal Evaluation
Lecture 8 Risk Categorization
Lecture 9 Recommendation of Action & Exchange of Information
Section 3: Analysis of data
Lecture 10 Data Analysis and Review of Different Sources
Lecture 11 Qualitative and Quantitative signal detection
Section 4: Format and Template of Signal Assessment Report
Lecture 12 Signal Assessment Report Template and Drafting
Section 5: Safety Governance Body
Lecture 13 Role of Safety Governance Body
Section 6: Congratulations
Lecture 14 Congratulations and Thank you
Pharmacovigilance ICSR and Aggregate Reporting experienced candidates,Graduate or Postgraduate degree in Pharmacy (e.g., B Pharm, M Pharm, M S Pharm, Pharm D),Graduate or Postgraduate degree in Medicine (MBBS, MD, BAMS, BUMS, BHMS),Graduate or Postgraduate degree in Life Sciences (BSc, MSc, PhD)


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