Pharmacovigilance Awareness for Healthcare Professionals
Scientific · Healthcare · Awareness
Foundational pharmacovigilance awareness for doctors, nurses, pharmacists and other healthcare professionals.
Job description
- Recognise adverse drug reactions (ADRs) in day-to-day clinical practice and understand their impact on individual patients.
- Apply safe prescribing and dispensing practices informed by product safety information.
- Report suspected adverse reactions completely and promptly to the relevant pharmacovigilance system.
- Communicate the benefits and risks of medicines to patients and colleagues.
Overall required level: Basic.This standard defines the pharmacovigilance awareness expected of any healthcare professional. It aligns closely with the WHO Pharmacovigilance Core Curriculum for University Teaching and requires knowledge at the Basic level.
Prerequisites
Mandatory prerequisites
- →Healthcare Professional occupation or student (e.g., doctor, nurse, pharmacist, other HCPs)
Recommendations
- →Basic working proficiency in English
- →Computer literacy
Concept of levels
Knowledge for each topic is assessed on a four-level scale.
| Level | Expected knowledge |
|---|---|
| N/A | No knowledge required. |
| Basic | Elementary knowledge of the specific regulation; fundamental understanding of the terms and definitions used, a basic understanding of the concept of the regulation, a general overview of what it covers and where it can be found; passive/delegated usage of the regulation. |
| Intermediate | Very good knowledge of the specific regulation; comprehensive understanding of the terms and definitions and of the concept and context of who/when/where/why/how it applies; active usage of the regulation when required. |
| Expert | Excellent knowledge of the specific regulation; in-depth understanding of the concept and of how and why its sections should be implemented and followed, including outcomes and responsibilities for all relevant stakeholders; active usage of the regulation on a daily basis. |
Knowledge
General Knowledge
| Topic | Level |
|---|---|
| Pharmacovigilance definition, aim, and objectives | Basic |
| Pharmacovigilance history | Basic |
| Stakeholders in pharmacovigilance | Basic |
| WHO UMC: Safety monitoring of medicinal products — Guidelines for setting up and running a Pharmacovigilance centre | Basic |
Regional Regulatory Specific Knowledge
Optional — mandatory only for local certificate variants.
| Topic | Level |
|---|---|
| Local regulatory authority guidance for HCPs (if applicable) | Basic |
Role Specific Knowledge
| Topic | Level |
|---|---|
| WHO UMC: The Safety of Medicines in Public Health Programmes — Pharmacovigilance, an essential tool | Basic |
| WHO UMC: Collecting high quality ADR reports (course available for HCPs) | Basic |
| WHO UMC: Essentials of pharmacovigilance communications (course available for HCPs) | Basic |
Knowledge · Skills · Attitude
A summary of the competency elements expected for this role.
| Element | Knowledge | Skills | Attitude |
|---|---|---|---|
| Understanding the importance of PV |
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| Preventing ADRs |
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| Recognising ADRs |
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| Managing ADRs |
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| Reporting ADRs |
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Get certified for this role
Certification validates prerequisites via CV screening and assesses knowledge through an online, AI-proctored examination based on the competency standard. The latest terms and requirements for every role and region are maintained by the Institute of Pharmacovigilance.
