Operational Pharmacovigilance: Analysing Signals, Managing Cases and Running the Reporting System
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MODULE 1...Mapping the players, roles and pharmacovigilance chain
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About
Detailed Presentation
The Operational Pharmacovigilance course is designed for health professionals and medicines safety practitioners who want to strengthen their practical skills in monitoring and managing medicine-related risks. Throughout this learning path, participants learn how to set up an effective pharmacovigilance system, improve the quality of reports, analyse safety signals, assess the causality of adverse reactions, manage health alerts and drive continuous improvement in surveillance systems. Based on WHO international frameworks, this course takes a resolutely hands-on approach, enriched by real-world cases from several French-speaking African countries and by tools that can be applied directly in health facilities, public health programmes and regulatory bodies.
Overview
What this course covers
Operational Pharmacovigilance: Analysing Signals, Managing Cases and Running the Reporting System is an online UpSkills course in Health & Social Care, organised into 6 modules, 20 lessons and 5h 15m of content. Each sequence pairs theory with hands-on practice so that what you learn transfers directly to a real professional setting.
By the end of this programme you will be able to by the end of this course, you will be able to:, understand how a pharmacovigilance system is organised and how it works, identify the adverse events and reactions that require reporting and set up reliable reporting pathways for adverse reactions. These skills are built up gradually across the course, consolidating the fundamentals before moving on to more advanced material.
The learning path opens with “SECTION 1 – Framing the operational pharmacovigilance system” and closes with “QUIZ”, taking in “SECTION 2 - Organising and ensuring reliable reporting of adverse effects”, “SECTION 3 - Analysing the signals: turning data into safety intelligence” and “SECTION 4 - Managing cases and handling health alerts” along the way. The sequence is designed so each module builds on the one before it.
This course is aimed at learners at intermediate level looking to build their skills in Health & Social Care. It suits both individual upskilling and a company-led development plan, and needs no special software or equipment to follow.
The programme is led by L'équipe d'experts Up Skills; you learn at your own pace, with no fixed schedule, from desktop, tablet or mobile.
What you'll learn
Key Objectives
By the end of this course, you will be able to:
Understand how a pharmacovigilance system is organised and how it works.
Identify the adverse events and reactions that require reporting.
Set up reliable reporting pathways for adverse reactions.
Improve the quality and completeness of reporting forms.
Reduce under-reporting through targeted, measurable actions.
Detect and analyse pharmacovigilance signals.
Apply the WHO-UMC and Naranjo methods for causality assessment.
Make use of data from VigiBase, VigiLyze and international alerts.
Document and communicate a validated signal effectively.
Manage serious cases and coordinate health alerts.
Identify and handle situations involving substandard or falsified medicines.
Organise pharmacovigilance within public health campaigns and mass programmes.
Build monitoring and performance dashboards.
Implement a continuous improvement approach based on the PDCA cycle.
Mobilise resources and build a lasting pharmacovigilance culture within health organisations.
Program
5 module(s)
MODULE 1
SECTION 1 – Framing the operational pharmacovigilance system
3 elementsMODULE 1...Mapping the players, roles and pharmacovigilance chain
19 minMODULE 2...Defining precisely what must be reported — and what must not be overlooked
16 minMODULE 3...Assessing the maturity of your system and prioritising strengthening measures
18 minMODULE 2
SECTION 2 - Organising and ensuring reliable reporting of adverse effects
4 elementsMODULE 4...Mastering the notification form: every field counts
18 minTools to download
MODULE 5...Structuring the reporting chain from the field to central level
17 minMODULE 6...Tackling under-reporting with targeted, measurable actions
18 minMODULE 3
SECTION 3 - Analysing the signals: turning data into safety intelligence
4 elementsMODULE 7...Understanding what a signal is and how it emerges
16 minMODULE 8...Assessing causality: the drug–effect link
16 minMODULE 9...Making the most of databases and international alerts
16 minMODULE 10...Documenting and communicating a validated signal
16 minMODULE 4
SECTION 4 - Managing cases and handling health alerts
4 elementsMODULE 11...Handling a serious case: from reporting to closure
18 minMODULE 12...Triggering and managing a health alert
18 minMODULE 13...Handling cases involving substandard and falsified medicines
17 minMODULE 14...Coordinating pharmacovigilance during a mass campaign
18 minMODULE 5
SECTION 5 - Steering, evaluating and improving the pharmacovigilance system
4 elementsMODULE 15...Building the PV system management dashboard
19 minMODULE 16...Continuous improvement: the PDCA cycle applied to pharmacovigilance
19 minMODULE 17...Mobilising resources and securing long-term funding for PV
19 minMODULE 18...Engaging stakeholders and building a pharmacovigilance culture
17 minMODULE 6
QUIZ
1 elementQUIZ
- Free sign-up — no payment at this step
- First capsule free, available right away
- You join this programme with your profile
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Secure payment
Requirements
Before you start
This course is aimed at health professionals — pharmacists, doctors, nurses, laboratory scientists, quality managers, health programme coordinators or anyone involved in medicines safety — who wish to deepen and structure their operational pharmacovigilance practice rather than discover the field. A grounding in medicines, patient care or public health is expected, and a general understanding of health surveillance or patient safety activities is an advantage. Confidence in analysing workplace situations and using monitoring and reporting tools is also recommended. A computer, tablet or smartphone with internet access is all you need to follow the course.