MedDRA Drug Safety & Adverse Event Coding Certification Course

Build Job-Ready MedDRA Coding Skills for Drug Safety, Adverse Event Reporting & Regulatory Roles

Learn how MedDRA (Medical Dictionary for Regulatory Activities) is used to classify, code and communicate adverse event information across the drug safety and regulatory ecosystem.

This structured certification course takes you from the fundamentals of MedDRA terminology to practical adverse event coding, SMQs, regulatory applications and case-based coding practice.

Whether you are a fresher looking to enter the life sciences industry or a professional looking to strengthen your drug safety skill set, this course will help you understand how MedDRA is applied in real-world safety and regulatory workflows.

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Course Highlights

✓ 10+ Structured Sessions

✓ Knowledge Test

✓ Beginner-Friendly Learning

✓ MedDRA Fundamentals to Practical Application

✓ Drug Safety-Focused Curriculum

✓ Adverse Event Coding Practice

✓ Case-Based Learning

✓ MedDRA Browser Navigation

✓ SMQ Learning & Demonstration

✓ Regulatory Reporting Concepts

✓ Career-Oriented Learning

✓ Industry-Relevant Skill Development

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How This Course Helps Your Career

If you are applying for life science industry roles, simply knowing the definition of Pharmacovigilance or Drug Safety may not be enough.

Employers increasingly look for candidates who understand the actual terminology, workflows and concepts used within the field.

MedDRA knowledge can help strengthen your profile by giving you exposure to an important component of adverse event and safety reporting.

You will be able to better understand:

How adverse events are interpreted → How medical concepts are identified → How appropriate MedDRA terminology is selected → How coded safety information supports reporting and regulatory activities.

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From Beginner to Applied MedDRA Coding

Step 1 – Understand MedDRA

Learn its purpose, structure, hierarchy and terminology.

Step 2 – Learn Coding Principles

Understand specificity, clinical accuracy and correct term selection.

Step 3 – Understand Drug Safety Applications

Learn how MedDRA fits into adverse event and safety reporting.

Step 4 – Explore Regulatory Applications

Understand FAERS, EudraVigilance, compliance and regulatory submissions.

Step 5 – Learn SMQs

Understand how related MedDRA terminology can be grouped and analysed.

Step 6 – Practise AE Coding

Apply your knowledge to adverse event scenarios and case-based exercises.

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Why Choose This MedDRA Certification Course?

Because this course is designed to teach you more than terminology definitions.

You will understand:

What MedDRA is

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How MedDRA terminology is structured

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How terms are selected

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How adverse events are coded

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How MedDRA supports drug safety and regulatory reporting

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How these skills connect with industry career pathways

Why Learn MedDRA?

When an adverse event is reported, the information cannot simply remain as free text.

It needs to be translated into standardised medical terminology so that safety information can be consistently analysed, communicated and reported.

This is where MedDRA plays a critical role.

MedDRA terminology is widely used across:

• Drug Safety
• Pharmacovigilance
• Clinical Research
• Clinical Trials
• Adverse Event Reporting
• Safety Data Management
• Regulatory Reporting
• Regulatory Affairs
• Safety Analysis

Developing MedDRA coding knowledge can therefore strengthen your profile for several roles across the pharmaceutical, biotechnology and clinical research industries.

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What Will You Learn?

Through 10+ structured learning sessions and a Knowledge Test, you will learn MedDRA step by step from terminology fundamentals to practical adverse event coding.

You Will Learn:

✓ Fundamentals of MedDRA

✓ MedDRA hierarchy and terminology structure

✓ SOC, HLGT, HLT, PT and LLT

✓ Primary and Secondary SOCs

✓ Multi-axiality in MedDRA

✓ Principles of accurate MedDRA coding

✓ LLT vs PT selection

✓ Adverse Event coding

✓ Common MedDRA coding mistakes

✓ Standardised MedDRA Queries – SMQs

✓ MedDRA Browser navigation

✓ MedDRA versioning and maintenance

✓ MedDRA in regulatory submissions

✓ MedDRA mapping in global safety reporting

✓ FDA FAERS and EMA EudraVigilance concepts

✓ Case-based adverse event coding

✓ Regulatory compliance and audit readiness

✓ Career opportunities involving MedDRA skills

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Course Curriculum

Session 1: Introduction to MedDRA

Build a strong foundation by understanding what MedDRA is, why it was developed and how it is used.

Topics Covered:

• What is MedDRA?

• Purpose and scope of MedDRA

• History and evolution

• Role of ICH

• Overview of MSSO

• Introduction to MedDRA and its features

Demonstration Included

Get an introduction to how the MedDRA interface and terminology environment are structured.

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Session 2: Importance of MedDRA & Its Usage

Understand why standardised terminology is essential for handling safety information.

Topics Covered:

• What is coding?

• Why is coding important?

• Importance of MedDRA

• Applications in Drug Safety

• Applications in Pharmacovigilance

• Applications in Clinical Trials

• Regulatory Reporting

• Industry applications of MedDRA

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Session 3: MedDRA Hierarchy & Structure

One of the most important parts of MedDRA is understanding how its terminology is organised.

Learn the complete five-level hierarchy:

SOC

System Organ Class

HLGT

High Level Group Term

HLT

High Level Term

PT

Preferred Term

LLT

Lowest Level Term

You will also understand:

• Grouping logic

• Navigation through MedDRA terminology

• Primary vs Secondary SOCs

• Multi-axiality

• How different terms relate to each other

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Session 4: MedDRA Versioning & Maintenance

MedDRA terminology is regularly updated to reflect developments in medical and regulatory terminology.

Topics Covered:

• MedDRA versioning cycle

• March and September updates

• How MedDRA terminology is maintained

• Change requests

• Addition and modification of terms

• Version comparison tools

• Version reports

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Session 5: Principles of MedDRA Coding

Learn the fundamental rules used when selecting the correct MedDRA terminology.

Topics Covered:

• Principles of term selection

• Importance of specificity

• Maintaining clinical accuracy

• Avoiding inappropriate upcoding

• LLT vs PT selection

• Common MedDRA coding mistakes

• Best practices for accurate coding

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Session 6: MedDRA in Regulatory Submissions

Understand how MedDRA supports consistent adverse event reporting and regulatory communication.

Topics Covered:

• MedDRA in global regulatory submissions

• Standardisation of adverse event reporting

• Regulatory communication

• MedDRA mapping

• FDA FAERS

• EMA EudraVigilance

• Consequences of non-compliance

• Regulatory expectations

• Audit readiness

This session helps you understand why accurate terminology and coding are important beyond individual case processing.

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Session 7: Introduction to Standardised MedDRA Queries – SMQs

Learn how groups of related MedDRA terms can be used to identify and analyse safety information.

Topics Covered:

• What are Standardised MedDRA Queries?

• Purpose of SMQs

• Grouping related medical concepts

• Navigation of related terms

• Practical SMQ examples

You will also explore examples such as grouping terms related to anaphylaxis.

Demonstration Included

Understand how terminology is grouped and navigated using SMQs.

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Session 8: How to Code an Adverse Event

This session moves from understanding terminology to actually applying it.

Topics Covered:

• Understanding the reported adverse event

• Identifying the medical concept

• Selecting the appropriate MedDRA term

• Avoiding terms that are too broad

• Avoiding terms that are too narrow

• Practical term-selection principles

• Common coding pitfalls

Practical Coding Included

Practise selecting appropriate MedDRA terminology for adverse event information.

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Session 9: Case-Based MedDRA Coding Practice

Apply your learning through realistic adverse event coding situations.

Practical Learning Includes:

• Reading an adverse event narrative

• Identifying relevant medical concepts

• Selecting appropriate LLTs

• Coding adverse events

• Navigating terminology

• Using the MedDRA Browser for term selection

• Case-based coding exercises

This session helps bridge the gap between knowing MedDRA terminology and actually applying it.

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Session 10: MedDRA Scope & Career Prospects

Understand how MedDRA skills fit into different career pathways within the life sciences industry.

Topics Covered:

• Industries that use MedDRA

• Job functions involving MedDRA

• Drug Safety opportunities

• Pharmacovigilance applications

• Clinical Research applications

• Regulatory applications

• Career growth

• Future opportunities

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Practical Learning – Not Just Theory

Learning definitions alone is not enough to understand MedDRA.

This program therefore includes practical exposure to important MedDRA applications.

MedDRA Navigation

Understand how MedDRA terminology is structured and how different levels of terminology are connected.

SMQ Navigation

Learn how related terms can be grouped using Standardised MedDRA Queries.

Adverse Event Coding

Practise identifying the medical concept from an adverse event and selecting an appropriate MedDRA term.

Case-Based Coding Practice

Work with adverse event narratives and apply MedDRA coding principles.

MedDRA Browser-Based Term Selection

Understand how terminology can be searched and selected while coding an adverse event.

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Build Skills Relevant to Drug Safety Careers

MedDRA is not simply another theoretical topic.

It is closely connected to how safety information is coded, analysed and communicated within the pharmaceutical and clinical research industries.

Learning MedDRA can help you develop a more job-relevant understanding of:

• Adverse Event Coding

• Drug Safety Terminology

• Safety Case Processing

• Safety Data Handling

• Regulatory Reporting

• Clinical Trial Safety

• Standardised Medical Terminology

• Regulatory Compliance

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Career Pathways

The skills covered in this course can be useful for candidates interested in career areas such as:

Drug Safety

Develop knowledge of terminology used while handling and reporting adverse event information.

Pharmacovigilance

Understand an important coding system used within safety reporting workflows.

Clinical Research

Learn how adverse event information from clinical studies can be standardised using MedDRA terminology.

Clinical Trial Safety

Understand terminology associated with adverse event documentation and safety reporting.

Regulatory Affairs

Learn how standardised terminology supports regulatory submissions and communication.

Safety Data Management

Develop a better understanding of how safety information is classified and organised.

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Who Should Join?

This certification course can be suitable for:

• BSc Life Science students

• MSc Life Science students

• Biotechnology students and graduates

• BPharm students and graduates

• MPharm students and graduates

• Clinical Research students

• Drug Safety aspirants

• Pharmacovigilance aspirants

• Clinical Data Management aspirants

• Regulatory Affairs aspirants

• Biotechnology professionals

• Pharmaceutical professionals

• Life Science freshers

• Professionals looking to add MedDRA knowledge to their existing skill set

No Prior MedDRA Knowledge?

That's absolutely fine.

The course begins with MedDRA fundamentals before gradually progressing into hierarchy, coding principles, regulatory applications, SMQs and case-based adverse event coding.

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Skills You Can Add to Your Profile

After completing the learning modules, you will have developed knowledge and practical understanding of:

MedDRA Coding

Adverse Event Coding

Drug Safety Terminology

SOC / HLGT / HLT / PT / LLT Hierarchy

LLT & PT Selection

Standardised MedDRA Queries – SMQs

MedDRA Browser Navigation

Regulatory Reporting Concepts

Safety Terminology

Case-Based Coding

Regulatory Compliance Concepts

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Add an In-Demand Drug Safety Skill to Your Profile

Build your understanding of MedDRA, Adverse Event Coding, SMQs and Regulatory Reporting through structured, career-oriented learning.

Whether you are preparing for your first opportunity in the pharmaceutical or clinical research industry or looking to strengthen an existing Drug Safety profile, this course can help you build a focused MedDRA skill set.

Enrol in the MedDRA Drug Safety & Adverse Event Coding Certification Course Today

Learn MedDRA. Practise Adverse Event Coding. Build Drug Safety Skills. Strengthen Your Industry Profile.