McKellar Institute
McKellar Institute
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Professional Certificate

AI in Pharmacovigilance &
Drug Safety

Build AI capability for the way drug safety is changing.

Explore how AI can support adverse event intake, case processing, signal detection, literature monitoring, aggregate reporting and risk management.

Self-pacedOnlineCertification
Starting level
White Belt2–3 weeks— no AI experience required
Progression
yellow4–6 weeksgreen8–10 weeksblack10–12 weeks
Drop the certification visual here — e.g. safety signal dashboard
Sample McKellar certificate
Professional Certificate awarded after every belt.
Verifiable. Shareable. Earned, not attended.
OverviewOutcomesBeltsFeesCredentialFAQStart White Belt

Built for drug safety. Enhanced by AI.

AI is already changing how safety teams identify adverse events, process cases, review literature, detect signals and prepare regulatory reports. But speed alone is not enough — patient safety, regulatory compliance, traceability, signal validity and human oversight remain essential. It is not simply about learning AI tools. It is about learning how to use AI within the standards of drug safety.

Detect

Use AI to support adverse event intake, case processing and coding.

Monitor

Explore AI-supported literature monitoring, surveillance and signal detection.

Evaluate

Judge AI outputs for reliability, compliance and explainability.

Full progression outcomes

Build capability you can use in practice.

By completing the full progression — through to Black Belt — you'll develop the ability to:

Identify meaningful AI applications across the pharmacovigilance lifecycle
Understand how NLP and AI are used in adverse event intake and case processing
Evaluate AI-generated MedDRA coding and case-classification outputs
Apply AI to literature monitoring, signal detection and safety surveillance
Interpret AI-supported quantitative signal outputs critically
Evaluate AI-enabled PV systems for reliability, compliance and operational suitability
Design human-in-the-loop controls for AI-assisted safety operations
Progress towards evaluating and leading AI transformation within pharmacovigilance
Your certification journey

One certification. Four levels of capability.

Start with the foundations and progress as far as your professional goals require.

White Belt · Foundation

Understand where AI fits in drug safety.

White Belt introduces AI in the language and context of pharmacovigilance — what AI can do, what it cannot do and where human professional responsibility remains essential.

I understand.

Explain AI, machine learning, NLP, generative AI and agentic AI in pharmacovigilance contexts
Map AI applications across the PV lifecycle from case intake through aggregate reporting
Distinguish between AI capability and human oversight responsibilities
Recognise common AI use cases in case processing, signal detection, literature surveillance and reporting
Identify important limitations such as hallucination, coding bias and explainability challenges
Understand the role of regulatory and data-protection frameworks in AI-enabled PV
Assess, at a basic level, the AI readiness of a pharmacovigilance team or organisation
01The AI-transformed pharmacovigilance landscape
02AI fundamentals for PV professionals
03AI across the PV lifecycle
04AI platforms & emerging capabilities
05Regulatory, ethical & data considerations
06Limitations & human oversight
Knowledge Assessment

40 domain-specific multiple-choice questions covering AI terminology, pharmacovigilance use cases, regulatory considerations, limitations, risk and human oversight. Pass ≥75%, 14-day window, unlimited attempts within it.

Professional Reflection & Peer Exchange

A short professional reflection per module plus substantive responses to at least two peers. Mandatory, formative and ungraded.

At a glance
Level
Foundation
Study mode
100% online, self-paced
Learning time
8–15 hours
Typical completion
2–3 weeks
Assessment
Knowledge Assessment + Professional Reflection & Peer Exchange
Credential
McKellar White Belt Professional Certificate — Digital Credential
Ready when you are
Pay per belt, or save with a Pathway Plan.
Register NowView Fees & Plans

Your capability develops with every belt.

Understandwhite
Applyyellow
Integrategreen
Leadblack

Each belt builds on the capability developed at the level before it.

Real-world applications

Where could AI change the way you work?

The full range of applications below reflects capability developed across the complete progression to Black Belt.

Adverse Event Intake

Support extraction and structuring of relevant safety information from unstructured sources.

Case Processing

Assist with classification, summarisation, coding and prioritisation while preserving mandatory review.

MedDRA Coding

Generate coding suggestions that remain subject to professional verification.

Literature Monitoring

Accelerate screening, relevance ranking and safety-information extraction.

Signal Detection

Support identification and prioritisation of potential safety signals across large datasets.

Risk Management

Assist with ongoing safety surveillance, risk identification and documentation.

Aggregate Reporting

Support structured drafting and evidence synthesis for periodic safety reports.

Regulatory Reporting

Improve consistency and efficiency across expedited and scheduled reporting workflows.

PV Quality & Compliance

Support inspection readiness, audit trails, quality metrics and compliance monitoring.

Built for your profession

For professionals responsible for turning safety data into responsible action.

Pharmacovigilance OfficersDrug Safety AssociatesSignal Management ProfessionalsSafety ScientistsPV ManagersMedical ReviewersRegulatory Safety ProfessionalsPV Quality ProfessionalsQPPV & Safety Leadership TeamsClinical Safety ProfessionalsPharmaceutical & CRO Professionals
No programming knowledge required.
No data-science background required.
No previous AI experience required for White Belt.
Earn a verifiable credential

Demonstrate capability.
Don't just watch videos.

Each belt has scenario-based assessments that require you to apply your knowledge in realistic drug-safety contexts.

Applied activities and practical tasks
Scenario-based assessments
Professional-context evaluation
Progressive capability standards
McKellar White Belt Professional Certificate — AI in Pharmacovigilance & Drug SafetyMcKellar Yellow Belt Professional Certificate — AI in Pharmacovigilance & Drug SafetyMcKellar Green Belt Professional Certificate — AI in Pharmacovigilance & Drug SafetyMcKellar Black Belt Professional Certificate — AI in Pharmacovigilance & Drug Safety
Certificate numberOnline verificationQR verificationDigital credentialShareable professional achievement
Assessment philosophy

Each belt answers a different question.

Assessment is applied and scenario-based — capability is demonstrated, not attended.

White Belt
Can you judge the fundamentals?
Knowledge + applied judgement
Yellow Belt
Can you apply AI to real problems?
Applied use + tool evaluation
Green Belt
Can you integrate and evaluate AI approaches?
Integration + capstone design
Black Belt
Can you lead and defend adoption decisions?
Implementation + professional defence

Overall indicative learning effort: approximately 120–165 hours across the full White-to-Black progression.

Choose how you progress

Start with White. Decide how far to go.

Each price is the fee for that single belt only — you pay per level, as you progress. All fees are in USD.

01
$399
White Belt
Foundation
02
$799
Yellow Belt
Practitioner
03
$1,399
Green Belt
Specialist
04
$2,299
Black Belt
Professional Leader

Pricing varies by country → View your fee

Not sure how far to go?

You don't need to decide today whether you'll complete all four belts.

New to AI in drug safety?White Belt
Building practitioner capability?White + Yellow
Want advanced capability?White → Green
Building toward leadership?Complete pathway

Regardless of how you pay, every learner begins at White and earns each belt sequentially.

What professionals say

Built for work beyond the classroom.

“The case-processing and signal examples were immediately relevant to my day-to-day safety work. I continued through to Green Belt.”

Priya Sharma
Drug Safety Associate · India
Green Belt

“It gave me the framework to introduce AI-assisted literature monitoring in our PV team — with the oversight our auditors expect.”

Thomas Weber
PV Manager · Germany
Black Belt

“Practical, honest about limitations and grounded in real pharmacovigilance practice. The belts build on each other well.”

Dr. Ana Sousa
Safety Scientist · Portugal
Yellow Belt

Illustrative testimonials — to be replaced with real learner feedback.

Want the details?

Take the certification guide with you.

Download the complete AI in Pharmacovigilance & Drug Safety guide, including curriculum, learning outcomes, assessment, belt progression and fees.

Download Certification Guide (PDF)
Have a question? Let our team help.
Frequently asked questions

Certification-specific answers.

No. White Belt is designed to establish the AI foundation.

Yes. The certification is designed around professional drug-safety practice rather than technical AI development.

Yes. Progression remains sequential, so you can continue from the next belt when you are ready.

Assessment becomes progressively more applied — from foundational knowledge at White Belt to tool evaluation, workflow design, capstone work and professional defence at advanced levels.

Yes. It is relevant to professionals working within pharmaceutical companies, CROs, safety-service providers and related drug-safety environments.

No. The certification focuses on professional application rather than training you to become a programmer.

No. Every learner begins at White Belt, and each belt is a credentialed milestone in its own right.

Yes. McKellar offers both pay-as-you-go and multi-level Pathway Plans.

Yes. Each successfully completed belt earns its own McKellar Professional Certificate and verifiable credential.

Ready to begin?

Drug safety is changing.
Build the capability to change with it.

Start with the foundations and progress from understanding AI to applying, integrating and ultimately leading its responsible use within pharmacovigilance.

Start White BeltDownload Certification Guide
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