The pharmacovigilance curriculum, built for how the job actually works

What PV is, the ethics and history it stands on, the vocabulary and workflow of the actual job, and where the discipline stands globally in 2026.

From The Drug Safety Coach's Global PV Career Course

• 1.1The Essence of Pharmacovigilance
• 1.2The Ethics Behind Every Rule — Nuremberg, Helsinki, Belmont & ICH E6(R3)
• 1.3Why Pharmacovigilance Matters — Historical Lessons
• 1.4The Evolution of Pharmacovigilance — Global and Indian Milestones
• 1.5Core Objectives and the Five Pillars of PV
• 1.6PV Core Vocabulary — AE, ADR, SAE, SUSAR & the Valid ICSR
• 1.7Your Actual Job — The 11-Step Workflow & Global Reporting Deadlines
• 1.8The Expanding Scope of Pharmacovigilance
• 1.9Pharmacovigilance in the Era of AI and Big Data
• 1.10India’s Pharmacovigilance Ecosystem — PvPI in 2026
• 1.11Pharmacovigilance as a Public-Health Responsibility
• 1.12Summary and What Comes Next
• 1.13Communicating Under Pressure: Follow-Up Letters, QC Comments & Escalation

The regulators, standards, and 2025–26 rule changes that govern PV worldwide.

From The Drug Safety Coach's Global PV Career Course

• 2.1Key Regulatory Authorities and Their Roles
• 2.2The ICH E2 Series — The Technical Backbone
• 2.3The WHO Programme for International Drug Monitoring and UMC
• 2.4CIOMS — Ethics, Harmonisation, and the AI Framework
• 2.5EMA Good Pharmacovigilance Practices (GVP) Modules
• 2.6EU Regulation 2025/1466 — The Most Significant EU PV Change Since 2012
• 2.7National PV Systems — EU, USA, India, Japan, and UK
• 2.8FDA–EMA Joint AI Guiding Principles (January 2026)
• 2.9The EU AI Act — Implications for Pharmacovigilance
• 2.10Global Data Exchange and Interoperability
• 2.11AI-Enabled Global Collaboration
• 2.12Summary and Key References
• 2.13CDSCO & PvPI: India’s Regulatory Framework in Depth

From preclinical toxicology to lifelong post-marketing surveillance — the full circular, AI-augmented lifecycle every case and signal fits into.

From The Drug Safety Coach's Global PV Career Course

• 3.1The Drug Development Continuum
• 3.2Preclinical Safety Evaluation
• 3.3Clinical Development — Safety in Phases I, II, and III
• 3.4Regulatory Review, Approval, and the Risk Management Plan
• 3.5Post-Marketing Surveillance — Where PV Lives
• 3.6Safety Responsibilities Across the Lifecycle
• 3.7The Lifecycle Feedback Mechanism
• 3.8Integration of PV with Regulatory Affairs, Clinical Research, and Quality
• 3.9AI Integration Across the Lifecycle (2026 Status)
• 3.10Lifecycle Governance and Living Safety Documentation
• 3.11The Benefit-Risk Balance — A Continuous Reassessment
• 3.12Summary and Key References
• 3.13CRA vs. PV: Understanding the Adjacent Career Path

The dictionary every case, signal, and aggregate report is built on — structure, governance, coding conventions, term selection, and SMQs.

From The Drug Safety Coach's Global PV Career Course

• 4.1Why MedDRA Coding Matters — and How This Module Lets You Practice It
• 4.2MedDRA: Structure, Governance, and the Five-Level Hierarchy
• 4.3Coding with MedDRA: Conventions, Term Selection, and SMQs
• 4.4Summary and Key References

The one part of every case a human actually reads — structure, objectivity, sequencing, and how single-case narratives roll up into PBRER line listings.

From The Drug Safety Coach's Global PV Career Course

• 5.1Why Narratives Are the Human Center of Every Case
• 5.2Anatomy of a Compliant Case Narrative
• 5.3Writing Objectively — Style, Tone, and the "Just the Facts" Discipline
• 5.4The Chronological Backbone
• 5.5Integrating MedDRA Terms Into Prose
• 5.6Common Narrative Errors and How Reviewers Catch Them
• 5.7Special Case Types — Death, Pregnancy, Overdose, and Device-Related Events
• 5.8Narratives for Serious vs. Non-Serious Cases — What Changes
• 5.9From Single-Case Narrative to Aggregate Line Listings
• 5.10AI-Assisted Narrative Drafting — Where It Helps and Where It Doesn’t
• 5.11Quality Check and Peer Review of Narratives
• 5.12Summary and Key References

The judgment calls every downstream PV activity depends on — WHO-UMC, Naranjo, the six seriousness criteria, expectedness, and how they combine into a SUSAR decision.

From The Drug Safety Coach's Global PV Career Course

• 6.1Why Causality Assessment Is the Hinge of Pharmacovigilance
• 6.2The WHO-UMC Causality Scale
• 6.3Challenge, Dechallenge, and Rechallenge
• 6.4The Naranjo Algorithm
• 6.5WHO-UMC vs. Naranjo — Strengths, Weaknesses, and When Each Is Used
• 6.6Company Causality vs. Regulatory/Reporter Causality
• 6.7The Six Seriousness Criteria Under ICH E2A
• 6.8The "Other Medically Important Condition" Catch-All
• 6.9Expectedness — Listed vs. Unlisted
• 6.10Putting It Together — the SUSAR Decision Path
• 6.11AI-Assisted Causality Support
• 6.12Summary and Key References

From a statistical flag to a validated signal to a label change — disproportionality analysis, the human review step, and where AI genuinely helps.

From The Drug Safety Coach's Global PV Career Course

• 7.1What Is a Safety Signal, Really?
• 7.2Sources of Signals
• 7.3Disproportionality Analysis — PRR, ROR, EBGM, and IC
• 7.4Reading a Signal in 3D — the Forest Plot
• 7.5Bayesian Shrinkage and Why Rare Events Need Special Handling
• 7.6From Statistical Flag to Validated Signal — the Human Review Step
• 7.7Signal Prioritisation
• 7.8The EU PRAC Signal Management Process
• 7.9VigiBase, EudraVigilance, and FAERS — Comparing the Big Databases
• 7.10AI/ML in Modern Signal Detection
• 7.11From Signal to Label Change — Closing the Loop
• 7.12Summary and Key References
• 7.13Literature Screening in Practice: Tools & Workflow

From individual-case judgment to cumulative judgment — PBRER structure, the data lock point, benefit-risk analysis, and how it all differs from a DSUR.

From The Drug Safety Coach's Global PV Career Course

• 8.1Why Aggregate Reports Exist
• 8.2PSUR vs. PBRER — What ICH E2C(R2) Actually Changed
• 8.3Anatomy of the PBRER
• 8.4The Data Lock Point and Reporting Interval
• 8.5Cumulative Exposure and the Denominator Problem
• 8.6Summarising Safety Findings
• 8.7The Benefit-Risk Analysis Section
• 8.8DSUR — The Clinical-Trial-Stage Cousin of the PBRER
• 8.9Regional Variations — CDSCO, FDA, PMDA, and EMA
• 8.10Common Deficiency Findings and How Quality Review Catches Them
• 8.11AI-Assisted Aggregate Report Drafting
• 8.12Summary and Key References

From reactive reporting to proactive planning — RMP structure, risk minimisation measures, the safety concern lifecycle, and how the EU and US approaches compare.

From The Drug Safety Coach's Global PV Career Course

• 9.1What Problem Does an RMP Actually Solve?
• 9.2RMP Structure — Parts I Through VI
• 9.3The Safety Specification
• 9.4Routine vs. Additional Risk Minimisation Measures
• 9.5The Pharmacovigilance Plan
• 9.6PAES vs. PASS — a Commonly Confused Pair
• 9.7Measuring Whether Risk Minimisation Actually Works
• 9.8The Safety Concern Lifecycle — Addition, Reclassification, Removal
• 9.9REMS in the US vs. the EU RMP
• 9.10The Public Summary of the RMP
• 9.11RMP Updates Across the Product Lifecycle
• 9.12Summary and Key References
• 9.13Patient Support Programs: A Hidden AE Volume Source

Where everything this course has covered actually lives — case form architecture, workflow, E2B(R3) transmission, validation, and how the major platforms compare.

From The Drug Safety Coach's Global PV Career Course

• 10.1Why the Database Matters as Much as the Science
• 10.2Oracle Argus Safety — Architecture and the Case Form
• 10.3ARISg — What’s Different, What’s the Same
• 10.4Veeva Vault Safety — the Cloud-Native Approach
• 10.5Case Intake, Duplicate Search, and Book-In
• 10.6Workflow States and Routing
• 10.7E2B(R3) — What the Database Actually Transmits
• 10.8Database-Driven Signal Detection Tools
• 10.9System Validation, Part 11 Compliance, and Audit Trails
• 10.10Choosing Between Databases — a Practical Comparison
• 10.11AI Layered on Top — Where Copilot Features Actually Sit in 2026
• 10.12Summary and Key References
• 10.13CRO Operations: SDEAs, Reconciliation & the Safety Mailbox

Who is legally accountable for a PV system, and the single master document that describes it to a regulator.

From The Drug Safety Coach's Global PV Career Course

• 11.1Why Accountability and Documentation Are Their Own Discipline
• 11.2The QPPV — Role, Legal Status, and Personal Accountability
• 11.3PVOIC and Global Equivalents — the Named-Person Requirement Around the World
• 11.4The PSMF — What It Actually Contains
• 11.5GVP Alignment — Keeping the PSMF and Company Practice in Sync
• 11.6Summary and Key References

How case-level QC, the PVQS, and a properly run CAPA cycle keep a PV system honest between inspections — and what actually happens once an inspector walks in.

From The Drug Safety Coach's Global PV Career Course

• 12.1Why Quality Systems Are Their Own Discipline
• 12.2Case-Level Quality Control
• 12.3The Pharmacovigilance Quality System (PVQS)
• 12.4CAPA — Corrective and Preventive Action, Done Properly
• 12.5Audit Programme Design — Risk-Based Approach
• 12.6Continuous Inspection Readiness — Culture, Not Event
• 12.7Inside an Inspection — What Actually Happens
• 12.8Summary and Key References
• 12.9Quality Metrics, KPIs & Working Under SLA

What AI actually does in production PV systems in 2026 — the taxonomy, the named platforms, the governance framework, and the human-in-the-loop discipline that makes all of it safe.

From The Drug Safety Coach's Global PV Career Course

• 13.1Why AI in PV Is Not Optional Anymore
• 13.2The AI Taxonomy — Six Types, One Field
• 13.3AI Across the Workflow, Part 1 — Intake, Coding, and Literature Monitoring
• 13.4AI Across the Workflow, Part 2 — Duplicates, Signals, Narratives, and Reports
• 13.5Agentic AI — The 2026 Frontier
• 13.6Platform Deep-Dive — Oracle Argus, Veeva Vault Safety, and ArisGlobal NavaX
• 13.7CIOMS WG XIV — The Seven Governance Principles
• 13.8The Regulatory Framework Map — CIOMS, EU AI Act, FDA-EMA, and GVP
• 13.9Building an AI Validation Dossier
• 13.10The Human-in-the-Loop Spectrum
• 13.11Designing HITL Workflows That Actually Work
• 13.12Summary, Career Implications, and Key References
• 13.13AI in the Daily Workflow: What Actually Changes for a Case Processor

Two parallel disciplines beyond conventional drug safety — AEFI classification and causality, active vaccine surveillance, and post-market device vigilance.

From The Drug Safety Coach's Global PV Career Course

• 14.1Why Vaccine Safety Surveillance Is Its Own Discipline
• 14.2AEFI — The Five WHO Categories
• 14.3AESI — Adverse Events of Special Interest
• 14.4AEFI Causality Assessment — The WHO Methodology
• 14.5Active Vaccine Safety Surveillance — VAERS, EudraVigilance, and Beyond
• 14.6Special Populations and Emergency Use — Pandemic Vaccine Vigilance
• 14.7From Vaccines to Devices — Why Materiovigilance Is a Parallel Discipline
• 14.8Device Risk Classification — Why It Determines Everything Else
• 14.9Device Incident Reporting — EU MDR Vigilance and FDA MedWatch/MAUDE
• 14.10Combination Products — Where Drug and Device Vigilance Meet
• 14.11UDI and Traceability — the Backbone of Modern Device Vigilance
• 14.12Summary and Key References
• 14.13Combination Products & PMSR: When Drug and Device Combine

How pharmacovigilance fills the gaps clinical trials leave behind — RWD sources, study design, confounding, OMOP, federated networks, and how RWE actually confirms a signal.

From The Drug Safety Coach's Global PV Career Course

• 15.1Why Clinical Trials Aren’t the Finish Line
• 15.2RWD vs. RWE — The Distinction That Determines Everything Else
• 15.3The Seven RWD Source Types
• 15.4Study Design, Part 1 — Cohort and Case-Control Studies
• 15.5Study Design, Part 2 — Self-Controlled and Specialised Designs
• 15.6Confounding — RWE’s Fundamental Limitation
• 15.7The OMOP Common Data Model
• 15.8Global Federated RWE Networks
• 15.9From Signal to Confirmed Risk — RWE and the Triangulation Principle
• 15.10AI and Machine Learning in RWE Analytics
• 15.11India’s RWE Landscape — PvPI, DPDP Act, and the Data Gap
• 15.12Summary and Key References

The drug-side counterpart to Module 4’s MedDRA — how a product itself gets uniquely, globally identified, and why that identification quality determines signal detection accuracy.

From The Drug Safety Coach's Global PV Career Course

• 16.1Why Drug-Side Coding Is Its Own Discipline
• 16.2The WHO Drug Dictionary (WHO-DD)
• 16.3The IDMP Standards — Five ISO Standards, One Framework
• 16.4XEVMPD, SPOR, and the EU’s Product Data Infrastructure
• 16.5Why Product Identification Quality Affects Signal Detection Directly
• 16.6Global Implementation Status and Practical Challenges
• 16.7Summary and Key References

From classroom to career — the ladder, the paths in, the resume and interview, and how to use this course whether you’re a medic, a pharmacist, a career-changer, a student, or a teacher.

From The Drug Safety Coach's Global PV Career Course

• 17.1Why This Module Exists — Serving Every Path Into PV
• 17.2The Career Ladder — From Entry-Level to QPPV
• 17.3Which Path Fits You — Medics, Pharmacists, and Career-Changers
• 17.4Building Your PV Resume and Portfolio
• 17.5The PV Interview — What Actually Gets Asked and Why
• 17.6Certifications, Professional Bodies, and Continuing Education
• 17.7Freelance, Remote, and Consulting Paths in PV
• 17.8Using This Course as an Academic Resource — For Students and Educators
• 17.9Summary and Key References
• 17.10Moving Into PV Leadership: CRO Client & Account Management