Certificate Course In Pharmacovigilance Signal Detection

Signal management, Signal detection, Signal validation, Signal assessment, Qualitative and Quantitative signal detection

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)