Pharmacovigilance Course: Drug Safety, Adverse Events & Safety Reporting

About Course

The Pharmacovigilance Course is a practical, career-focused program designed to provide learners with essential knowledge and skills in drug safety, adverse event reporting, case processing, safety assessment, and regulatory compliance.

The course covers the complete pharmacovigilance lifecycle, from identification and collection of adverse event information to case processing, medical review, coding, causality assessment, follow-up, safety reporting, and quality control.

Through practical examples, case studies, sample safety reports, and hands-on exercises, participants will develop a strong foundation for careers in pharmacovigilance, drug safety, clinical research, regulatory affairs, and the pharmaceutical and healthcare industries.

Understand the fundamentals and importance of pharmacovigilance
Identify and classify adverse events and adverse drug reactions
Understand the structure and requirements of ICSRs
Process and document safety cases systematically
Assess case validity and identify duplicates
Understand MedDRA and basic medical coding concepts
Assess seriousness, severity and causality
Write clear and structured case narratives
Handle special situations in pharmacovigilance
Understand aggregate safety reporting concepts
Understand signal detection and risk-management principles
Apply basic pharmacovigilance quality and compliance practices
Understand the role of AI and technology in modern drug safety
Develop practical skills for entry-level pharmacovigilance and drug-safety roles

Course Content

Introduction to Pharmacovigilance
Meaning and importance of pharmacovigilance History and evolution of drug safety Objectives of pharmacovigilance Role of pharmacovigilance in patient safety Drug safety lifecycle Roles and responsibilities of pharmacovigilance professionals

Adverse Events & Adverse Drug Reactions
Adverse Event (AE) Adverse Drug Reaction (ADR) Serious and non-serious events Expected and unexpected events Identifying reportable safety information Special situations in pharmacovigilance

Individual Case Safety Reports (ICSR)
. Individual Case Safety Reports (ICSR) Introduction to ICSRs Sources of safety information Minimum criteria for a valid case Case intake and triage Data collection Case creation and documentation Follow-up information

ICSR Case Processing
Case receipt and data entry Duplicate case identification Case validity assessment Narrative writing Medical review Quality review Case closure and follow-up

Medical Coding
Introduction to medical coding MedDRA terminology Coding adverse events Coding indications and medical history Coding investigations and procedures Coding accuracy and consistency

Seriousness, Severity & Causality
Seriousness criteria Severity assessment Expectedness Causality assessment concepts Relationship between drug and event Clinical evaluation of safety information

Special Situations
Medication errors Overdose Misuse and abuse Off-label use Pregnancy and lactation exposure Lack of efficacy Product quality complaints with safety implications Occupational exposure

Aggregate Safety Reporting
Purpose of aggregate safety reports Periodic safety reporting concepts Development Safety Update Reports Periodic Benefit-Risk Evaluation Reports Signal-related safety information Benefit-risk assessment fundamentals

Signal Detection & Risk Management
Introduction to safety signals Signal identification Signal validation Signal assessment Risk identification and evaluation Risk minimization concepts Benefit-risk management

Regulatory & Compliance
Global pharmacovigilance framework Introduction to ICH guidelines Good Pharmacovigilance Practices (GVP) Regulatory reporting requirements Pharmacovigilance inspections Standard Operating Procedures (SOPs) Documentation and audit readiness

Pharmacovigilance Quality Management
Quality control and quality assurance Case-processing quality checks Compliance monitoring Timelines and reporting requirements Deviation management Corrective and Preventive Actions (CAPA) Audit and inspection readiness

Pharmacovigilance with AI & Technology
Introduction to AI in drug safety Automation in case processing AI-assisted safety data review Natural language processing concepts Signal detection technologies Benefits and limitations of automation Data privacy and responsible use of AI

Practical Pharmacovigilance Training
ICSR case-processing exercises Case validity assessment MedDRA coding exercises Seriousness and causality assessment Narrative writing Duplicate case assessment Follow-up case processing Safety-report review Case-based pharmacovigilance assignments

Pharmacovigilance Course: Drug Safety, Adverse Events & Safety Reporting

About Course

What Will You Learn?

Course Content

Introduction to Pharmacovigilance
Meaning and importance of pharmacovigilance History and evolution of drug safety Objectives of pharmacovigilance Role of pharmacovigilance in patient safety Drug safety lifecycle Roles and responsibilities of pharmacovigilance professionals

Adverse Events & Adverse Drug Reactions
Adverse Event (AE) Adverse Drug Reaction (ADR) Serious and non-serious events Expected and unexpected events Identifying reportable safety information Special situations in pharmacovigilance

Individual Case Safety Reports (ICSR)
. Individual Case Safety Reports (ICSR) Introduction to ICSRs Sources of safety information Minimum criteria for a valid case Case intake and triage Data collection Case creation and documentation Follow-up information

ICSR Case Processing
Case receipt and data entry Duplicate case identification Case validity assessment Narrative writing Medical review Quality review Case closure and follow-up

Medical Coding
Introduction to medical coding MedDRA terminology Coding adverse events Coding indications and medical history Coding investigations and procedures Coding accuracy and consistency

Seriousness, Severity & Causality
Seriousness criteria Severity assessment Expectedness Causality assessment concepts Relationship between drug and event Clinical evaluation of safety information

Special Situations
Medication errors Overdose Misuse and abuse Off-label use Pregnancy and lactation exposure Lack of efficacy Product quality complaints with safety implications Occupational exposure

Aggregate Safety Reporting
Purpose of aggregate safety reports Periodic safety reporting concepts Development Safety Update Reports Periodic Benefit-Risk Evaluation Reports Signal-related safety information Benefit-risk assessment fundamentals

Signal Detection & Risk Management
Introduction to safety signals Signal identification Signal validation Signal assessment Risk identification and evaluation Risk minimization concepts Benefit-risk management

Regulatory & Compliance
Global pharmacovigilance framework Introduction to ICH guidelines Good Pharmacovigilance Practices (GVP) Regulatory reporting requirements Pharmacovigilance inspections Standard Operating Procedures (SOPs) Documentation and audit readiness

Pharmacovigilance Quality Management
Quality control and quality assurance Case-processing quality checks Compliance monitoring Timelines and reporting requirements Deviation management Corrective and Preventive Actions (CAPA) Audit and inspection readiness

Pharmacovigilance with AI & Technology
Introduction to AI in drug safety Automation in case processing AI-assisted safety data review Natural language processing concepts Signal detection technologies Benefits and limitations of automation Data privacy and responsible use of AI

Practical Pharmacovigilance Training
ICSR case-processing exercises Case validity assessment MedDRA coding exercises Seriousness and causality assessment Narrative writing Duplicate case assessment Follow-up case processing Safety-report review Case-based pharmacovigilance assignments

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About Course

What Will You Learn?

Course Content

Introduction to Pharmacovigilance Meaning and importance of pharmacovigilance History and evolution of drug safety Objectives of pharmacovigilance Role of pharmacovigilance in patient safety Drug safety lifecycle Roles and responsibilities of pharmacovigilance professionals

Adverse Events & Adverse Drug Reactions Adverse Event (AE) Adverse Drug Reaction (ADR) Serious and non-serious events Expected and unexpected events Identifying reportable safety information Special situations in pharmacovigilance

Individual Case Safety Reports (ICSR) . Individual Case Safety Reports (ICSR) Introduction to ICSRs Sources of safety information Minimum criteria for a valid case Case intake and triage Data collection Case creation and documentation Follow-up information

ICSR Case Processing Case receipt and data entry Duplicate case identification Case validity assessment Narrative writing Medical review Quality review Case closure and follow-up

Medical Coding Introduction to medical coding MedDRA terminology Coding adverse events Coding indications and medical history Coding investigations and procedures Coding accuracy and consistency

Seriousness, Severity & Causality Seriousness criteria Severity assessment Expectedness Causality assessment concepts Relationship between drug and event Clinical evaluation of safety information

Special Situations Medication errors Overdose Misuse and abuse Off-label use Pregnancy and lactation exposure Lack of efficacy Product quality complaints with safety implications Occupational exposure

Aggregate Safety Reporting Purpose of aggregate safety reports Periodic safety reporting concepts Development Safety Update Reports Periodic Benefit-Risk Evaluation Reports Signal-related safety information Benefit-risk assessment fundamentals

Signal Detection & Risk Management Introduction to safety signals Signal identification Signal validation Signal assessment Risk identification and evaluation Risk minimization concepts Benefit-risk management

Regulatory & Compliance Global pharmacovigilance framework Introduction to ICH guidelines Good Pharmacovigilance Practices (GVP) Regulatory reporting requirements Pharmacovigilance inspections Standard Operating Procedures (SOPs) Documentation and audit readiness

Pharmacovigilance Quality Management Quality control and quality assurance Case-processing quality checks Compliance monitoring Timelines and reporting requirements Deviation management Corrective and Preventive Actions (CAPA) Audit and inspection readiness

Pharmacovigilance with AI & Technology Introduction to AI in drug safety Automation in case processing AI-assisted safety data review Natural language processing concepts Signal detection technologies Benefits and limitations of automation Data privacy and responsible use of AI

Practical Pharmacovigilance Training ICSR case-processing exercises Case validity assessment MedDRA coding exercises Seriousness and causality assessment Narrative writing Duplicate case assessment Follow-up case processing Safety-report review Case-based pharmacovigilance assignments

Introduction to Pharmacovigilance
Meaning and importance of pharmacovigilance History and evolution of drug safety Objectives of pharmacovigilance Role of pharmacovigilance in patient safety Drug safety lifecycle Roles and responsibilities of pharmacovigilance professionals

Adverse Events & Adverse Drug Reactions
Adverse Event (AE) Adverse Drug Reaction (ADR) Serious and non-serious events Expected and unexpected events Identifying reportable safety information Special situations in pharmacovigilance

Individual Case Safety Reports (ICSR)
. Individual Case Safety Reports (ICSR) Introduction to ICSRs Sources of safety information Minimum criteria for a valid case Case intake and triage Data collection Case creation and documentation Follow-up information

ICSR Case Processing
Case receipt and data entry Duplicate case identification Case validity assessment Narrative writing Medical review Quality review Case closure and follow-up

Medical Coding
Introduction to medical coding MedDRA terminology Coding adverse events Coding indications and medical history Coding investigations and procedures Coding accuracy and consistency

Seriousness, Severity & Causality
Seriousness criteria Severity assessment Expectedness Causality assessment concepts Relationship between drug and event Clinical evaluation of safety information

Special Situations
Medication errors Overdose Misuse and abuse Off-label use Pregnancy and lactation exposure Lack of efficacy Product quality complaints with safety implications Occupational exposure

Aggregate Safety Reporting
Purpose of aggregate safety reports Periodic safety reporting concepts Development Safety Update Reports Periodic Benefit-Risk Evaluation Reports Signal-related safety information Benefit-risk assessment fundamentals

Signal Detection & Risk Management
Introduction to safety signals Signal identification Signal validation Signal assessment Risk identification and evaluation Risk minimization concepts Benefit-risk management

Regulatory & Compliance
Global pharmacovigilance framework Introduction to ICH guidelines Good Pharmacovigilance Practices (GVP) Regulatory reporting requirements Pharmacovigilance inspections Standard Operating Procedures (SOPs) Documentation and audit readiness

Pharmacovigilance Quality Management
Quality control and quality assurance Case-processing quality checks Compliance monitoring Timelines and reporting requirements Deviation management Corrective and Preventive Actions (CAPA) Audit and inspection readiness

Pharmacovigilance with AI & Technology
Introduction to AI in drug safety Automation in case processing AI-assisted safety data review Natural language processing concepts Signal detection technologies Benefits and limitations of automation Data privacy and responsible use of AI

Practical Pharmacovigilance Training
ICSR case-processing exercises Case validity assessment MedDRA coding exercises Seriousness and causality assessment Narrative writing Duplicate case assessment Follow-up case processing Safety-report review Case-based pharmacovigilance assignments