Pharmacovigilance
The system through which adverse reactions and other medicine-related problems are detected, assessed, understood and prevented.
- Patient safety & benefit-risk
- Post-authorisation surveillance
- Safety decisions & communication
Free trainingEU PharmacovigilanceRole-based learning
From the first report to risk management.
A complete pharmacovigilance learning hub for people and teams across the pharmaceutical sector: safety information recognition, correct intake, ICSR processing, EudraVigilance, literature, signals, PSUR/RMP, risk minimisation, QPPV/PSMF and quality oversight.
12core learning stages
9role-based pathways
3knowledge levels
Foundation
What it is and why it exists.
Pharmacovigilance protects patients throughout the lifecycle of a medicine. Training should match each role and stay current because data sources, technologies, processes and regulatory requirements continue to evolve.
Training is part of the system
GVP Module I requires initial and continued training for people performing pharmacovigilance activities, linked to their roles and responsibilities and supported by training plans and records.
- Training needs assessment
- Role-based competence
- Effectiveness & refreshers
Everyone can be a safety intake point
Sales, Medical Information, Quality, Regulatory, Legal, Clinical, Marketing and other functions may receive safety information. At minimum, they need awareness and a clear route-to-PV process.
- Recognise
- Capture what is available
- Forward without delay
1AwarenessWhat counts as safety information.
2IntakeSource, day zero, minimum criteria.
3AssessmentValidity, seriousness, follow-up.
4ProcessingCoding, narrative, quality review.
5SubmissionE2B(R3), EudraVigilance, timelines.
6SurveillanceLiterature, reconciliation, signals.
7Benefit-riskPSUR, RMP, safety evaluation.
8ActionRisk minimisation, communication, CAPA.
26
2026 regulatory transition — important for current training
ICH E2D(R1) has a legal effective date in the EU of 18 March 2026. EMA provided a transition period until 18 September 2026; after that date the updated definitions and related guidance apply. In parallel, Implementing Regulation (EU) 2025/1466 amended Regulation 520/2012. EMA ICH E2D(R1) · EU 2025/1466
Interactive tool
PV Case Compass.
An immediate educational decision aid for the first handling of potential safety information. It does not ask for names or personal data and does not replace an SOP, medical assessment or regulatory judgement.
Educational routing result
Start with recognition.
No assessment yetComplete the characteristics of the situation. The tool will show what to consider first, what not to miss and which official source to open.
Golden ruleWhen someone in the company receives potential safety information, they do not wait to “prove” causality before forwarding it to the appropriate PV function.
Do not enter personal data hereUse your company-approved intake process / safety database for real cases.
For real obligations, follow current SOPs, local requirements, GVP/ICH guidance and the assessment of the responsible Pharmacovigilance function.
Curriculum
12 learning stages.
From foundation awareness to system oversight. Each stage connects specific roles with official sources and practical application.
Role-based development
Learning paths by role.
Not everyone needs the same depth of training. Learning should match the likelihood of encountering safety information, the decisions a person makes and their responsibility within the PV system.
Career & operating model
Roles in pharmacovigilance.
Pharmacovigilance is multidisciplinary. Some roles collect and process cases, others assess medical data, while others manage signals, systems, compliance and governance.
Job aids
Practical job aids.
Short checklists for daily use and team training. They are memory aids, not substitutes for approved SOPs.
Minimum criteria prompt
To consider whether a potentially valid ICSR exists, check for:
- identifiable patient
- identifiable reporter
- suspect medicinal product
- suspected adverse reaction
Day-zero mindset
Do not “park” safety information in an inbox or personal file.
- Record when it became known
- Forward without unjustified delay
- Keep source & context
- Let the PV function assess reportability
Serious ≠ severe
Seriousness is a regulatory concept and is not the same as the intensity or severity of an event.
- death / life-threatening
- hospitalisation
- disability
- congenital anomaly
- other medically important condition
Follow-up checklist
The goal is to improve clinical completeness without leading the reporter.
- event details & outcome
- dates / dose / indication
- medical history & concomitants
- tests / treatment / dechallenge-rechallenge
- missing seriousness information
PV + Quality dual route
A technical product complaint with an adverse event may require simultaneous Quality and PV routing.
- Do not choose only one function
- Maintain a cross-reference
- Reconcile quality & safety records
- Escalate critical product defects promptly
Signal thinking
A signal is not simply “many cases”. It requires evidence, context, medical judgement and documented decision-making.
- detection
- validation
- analysis & prioritisation
- assessment
- recommendation / action
Regulatory map
Legislation & official sources.
This site is a navigation guide. For real decisions, always open the current official version of the source and confirm how it applies to the specific product, market and process.
EU / EMA framework
Practice & reporting resources
Quick reference
Mini PV glossary.
Core terms that appear repeatedly in safety operations, training, audits and inspections.
Free assessment
Knowledge Test.
Choose a level. Each attempt draws 6 random questions from a 12-question pool for that level, with shuffled answer order, explanation and an official source for further study.
PV Knowledge Check
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Assessment complete
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