Literature Monitoring in Pharmacovigilance

Name: Literature Monitoring in Pharmacovigilance
Rating: 4.1 (70 reviews)

Medical Literature monitoring, Medline, Embase (Elsevier), PubMed, Literature database, Literature surveillance

Created byPV Drug Safety Academy

Last updated 1/2026

English

English [Auto],

What you'll learn

Introduction and Basics
Types of Literatures & Search strategies
Literature monitoring guidance from FDA and EMA
Sources used for Literature review
How to review Literature articles
Different Literature databases
Demo of Literature database
Role of Literatures in Case processing, Aggregate reports & Signal detection

Course content

5 sections • 17 lectures • 2h 4m total length

Topics to be discussed5:24
Learn how literature monitoring fuels pharmacovigilance across five modules, from basics and search strategies to databases and its roles in case processing, reporting, and signal management.
Introduction and Basics25:03
Learn how literature monitoring in pharmacovigilance identifies adverse events, detects safety signals, and informs post-marketing risk-benefit assessments using Medline and Embase for safety reviews.
Literature search, monitoring, and screening6:21
Explore literature search, monitoring, and screening to identify ICSR reports and detect safety signals. Ensure the four minimum criteria: identified reporter, identified patient, company product, adverse events.
Why search the scientific and medical literature?3:50
Explore why searching the scientific and medical literature is essential in pharmacovigilance to assess safety, monitor risk-benefit balance, support expedited reporting, periodic reports, and signal detection, guiding regulatory decisions.
What type of information to be reviewed3:25
Review literature for case processing, signal detection, and regulatory documents (dsr, pbrer, aco addenda), focusing on new or unexpected information with potential causal relevance, including pregnancy outcomes and pediatric data.
Sources used for the literature review9:39
Learn about literature review sources, including the EMA MLM service, global databases such as PubMed and Embase, and local non-index literature, and how marketing authorisation holders monitor safety.
Quiz

Types of Literature articles10:20
Classify medical literature into original articles, review articles, and case reports, highlighting randomized controlled trials as gold-standard methods. Distinguish primary, secondary, and tertiary literature to guide pharmacovigilance literature monitoring.
Types of Literature searches7:54
Compare exhaustive (systematic) and selective literature searches, and contrast global versus local approaches, highlighting how research questions, scope, and resources guide method choice; emphasize high impact literature and databases.
Literature Search Strategies8:46
Develop a robust literature search strategy by choosing keywords, databases, synonyms, and filters; apply boolean operators to refine results and critically appraise sources.
Literature monitoring guidance from FDA and EMA4:34
Explore FDA and EMA guidance on literature monitoring, including FDA's good pharmacovigilance practices and EMA's module six for adverse reaction reporting and EudraVigilance responsibilities.
Quiz

Medline3:35
Explore how databases like Medline, PubMed, Embase, and ClinicalTrials.gov support literature reviews, with Medline providing biomedicine coverage searchable via PubMed, weekly updates across 5200 journals.
Embase (Elsevier)3:10
Embase (Elsevier) offers a high-quality, comprehensive medical literature database with about 32 million records from 8500 journals, spanning 1947 to present and global coverage across 95 countries.
PubMed3:26
PubMed is a freely available database focused on Medline, maintained by the National Library of Medicine. It provides standard and comprehensive searches with MeSH terms, boolean operators, and mobile access.
Clinicaltrials.gov2:53
Explore ClinicalTrials.gov, a National Library of Medicine registry with over 444,000 trials across 221 countries, and learn its search options, timelines, and reporting of results and adverse events.
Quiz

Demo of PubMed7:30
Explore the PubMed literature database with advanced search, apply filters by time, language, and species, and review abstracts or full text to evaluate bevacizumab case reports and adverse events.
Demo of Clinicaltrials dot [.] gov5:16
Navigate the clinicaltrials.gov portal to search diabetes insulin studies, apply filters, and review NCT numbers, inclusion criteria, and study outcomes for pharmacovigilance.

Requirements

PC/ Laptop/ Cellphone
Good Internet connection
Basic English

Description

Course Title: Literature Monitoring in Pharmacovigilance

Course Description:

Unlock the essential skills needed to excel in pharmacovigilance with our comprehensive course on "Literature Monitoring in Pharmacovigilance". Designed for healthcare professionals, regulatory affairs specialists, and anyone interested in drug safety, this course provides in-depth knowledge and practical tools to effectively monitor and evaluate scientific literature for adverse drug reactions (ADRs).

What You'll Learn:

Literature Search Techniques
Data Extraction and Analysis
Literature monitoring guidance from FDA and EMA
Sources used for Literature review
How to review Literature articles
Different Literature databases
Role of Literatures in Case processing, Aggregate reports & Signal detection
Demo of PubMed Literature database

Why Enroll:

Expert Instructors: Learn from industry professionals with extensive experience in pharmacovigilance.
Flexible Learning: Access course materials anytime, anywhere, and learn at your own pace.
Certification: Earn a certificate of completion to enhance your professional credentials.
Community Support: Join a community of learners and professionals to share insights and experiences.

Who Should Enroll:

Pharmacovigilance professionals
Regulatory affairs specialists
Healthcare providers
Students and graduates in life sciences

So what are you waiting for? Enroll now to advance your career in pharmacovigilance and ensure the safety and efficacy of pharmaceutical products through effective "Literature monitoring in Pharmacovigilance".

Who this course is for:

Pharmacovigilance professionals
Pharmacy, Medical and Life science students
Clinical Research professionals

Literature Monitoring in Pharmacovigilance

What you'll learn

Explore related topics

Course content

Module I - Introduction and Background6 lectures • 54min

Module II - Types of Literatures, Search strategies, Guidance from Industry4 lectures • 32min

Module III - Different Literature databases4 lectures • 13min

Module IV - Demo of PubMed and Clinicaltrials dot gov2 lectures • 13min

Congratulations & Thank you1 lecture • 13min

Requirements

Description

Who this course is for: