Global Pharmacovigilance Operations Certification

Global pharmacovigilance is not a single skill — it is an operational system. At its foundation are the regulatory frameworks that define what must be reported, when, and how. On top of that sits the case processing workflow — intake, triage, coding, narrative, submission, closure. Underneath it all are the databases and technology systems that store, transmit, and analyse safety data across every market where a drug is sold. A complete pharmacovigilance professional needs to operate across all three layers fluently. Most candidates can describe one. Almost none can demonstrate all three.

This program builds that complete operational picture from the ground up. You start where the industry starts — understanding what pharmacovigilance is, who regulates it globally, what Good Pharmacovigilance Practices require, and how the roles and responsibilities inside a drug safety department actually map to real work. From there you move into the full ICSR workflow — case intake, source document review, AI-assisted triage, MedDRA coding, quality checks, submission timelines, and case closure — before progressing into the systems and databases that the global PV infrastructure runs on: E2B(R3), Oracle Argus Safety, ARISg, VigiBase, and FAERS. MedDRA is trained across multiple dimensions — hierarchy architecture, LLT to SOC coding logic, AI-assisted auto-coding, complex case handling, version management, and error resolution — integrated throughout the workflow rather than isolated as a standalone module.

By the end you carry a multi-system operations portfolio that documents execution across the complete pharmacovigilance technology stack. In an industry where most candidates arrive with knowledge of one system and none of the others, that breadth — demonstrated and advisor-verified — is the difference between a shortlist and a rejection.

You are dropped into a simulated global pharmacovigilance operation. A new spontaneous adverse event report arrives. Your job — end to end:

Classify the event against regulatory definitions. Is it an AE, SAE, or ADR? Apply GVP-compliant assessment criteria. Open the ICSR in the Argus Safety case workbench. Enter patient, reporter, and product data across all mandatory fields. Run AI-assisted triage to assess validity and seriousness priority. Apply MedDRA coding — navigate the hierarchy, find the correct LLT, verify the PT, confirm the SOC. Use the AI auto-coding tool and validate its output against the source document. Check submission timelines — does this case require 7-day or 15-day expedited reporting? Generate the E2B(R3) case record and validate it for transmission. Query VigiBase to check global reporting context for the event-drug combination. Cross-reference against FAERS for US market signal context. Manage data privacy requirements across jurisdictions. Close the case with complete quality documentation.

That is the baseline module. Each subsequent scenario adds operational complexity — multi-market reporting obligations, blinded clinical trial cases, database reconciliation errors, MedDRA version transitions, system integration failures. You build operational fluency across every layer of the global PV stack.