Real-world case processing, AI-powered systems, and enterprise workflows

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Available in two formats: 3-Month Accelerator | 6-Month Deep Dive

Fully online. Self-paced. Start immediately.

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This program trains you to process adverse event cases, manage drug safety data, and operate pharmacovigilance systems the way they're actually used in pharmaceutical companies and contract research organizations worldwide.

You'll work inside simulated drug safety environments where you handle real case scenarios, use industry-standard tools, and apply regulatory guidelines under realistic conditions. By the end, you can demonstrate documented competence in the core functions pharmaceutical companies need from day one.

 

What You'll Actually Learn

Foundations of Pharmacovigilance

You start with the regulatory framework and operational basics: understanding global PV regulatory bodies (FDA, EMA, WHO), distinguishing between AEs, SAEs, and ADRs, learning Good Pharmacovigilance Practices (GVP), and getting introduced to MedDRA terminology and AI applications in pharmacovigilance. You'll understand PV roles, documentation standards, and the historical context that shapes current practice.

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Individual Case Safety Report (ICSR) Processing

You'll master the complete ICSR lifecycle from intake through closure. This includes source document review, adverse event causality assessment using WHO-UMC criteria, MedDRA coding for adverse events, narrative writing following regulatory standards, AI-assisted case triage, quality control procedures, understanding submission timelines and reporting rules, and proper case closure documentation.

 

Global PV Systems and Databases

You'll work with the actual systems used in pharmaceutical safety operations: E2B(R3) electronic transmission standards, VigiBase navigation and queries, FAERS data reconciliation, Argus Safety System workflows, ARISg system basics, AI-assisted database queries, data privacy protocols, database error handling, and system integration procedures.

 

Signal Detection and Risk Management

You'll learn both quantitative and qualitative signal detection methods, including disproportionality analysis (PRR, ROR, IC values), AI-powered signal noise reduction, signal validation processes, Risk Management Plan (RMP) development, signal reporting standards, risk minimization strategies, and building signal detection dashboards.

 

Aggregate Safety Reporting

You'll compile and analyze periodic safety data for regulatory submissions: PSUR (Periodic Safety Update Report) requirements and timelines, DSUR (Development Safety Update Report) basics, data aggregation techniques, AI-assisted PSUR drafting, line listings and summary tabulations, quality checks for aggregate reports, handling regulatory queries, and report automation workflows.

 

MedDRA Coding and Case Quality

You'll master the MedDRA hierarchy (LLT, PT, SOC levels), AI-assisted auto-coding, coding accuracy and quality checks, complex case coding scenarios, narrative quality standards, follow-up case processing, coding error resolution, managing MedDRA version updates, and using case quality dashboards.

 

PV Audits and Inspections

You'll prepare for regulatory oversight: understanding FDA and EMA audit requirements, CAPA (Corrective and Preventive Action) management for findings, AI-assisted audit trail maintenance, mock audit simulations, handling inspection queries, document control procedures, post-audit reporting, and maintaining continuous compliance.

 

Risk Management and Safety Communication

You'll develop and distribute safety communications: drafting Dear Healthcare Professional letters, patient safety notifications, working with Data Safety Monitoring Boards (DSMB), stakeholder engagement protocols, risk communication metrics, handling public safety queries, crisis communication procedures, and global safety communication standards.

 

Post-Marketing Surveillance

You'll monitor drug safety after market approval: using real-world evidence for pharmacovigilance, AI-driven post-marketing signal detection, literature monitoring for safety signals, social media safety surveillance, handling post-marketing queries, safety label updates, compiling post-marketing reports, and global harmonization practices.

 

Advanced AI in Pharmacovigilance

You'll integrate cutting-edge technology into PV operations: automated case processing systems, Natural Language Processing (NLP) for adverse event narrative analysis, predictive analytics applications, AI-driven workflow automation, blockchain for data integrity, understanding ethics and bias in PV AI systems, AI-based dashboards, and future trends in pharmacovigilance technology.

 

PV Operations and Systems Integration

You'll understand end-to-end pharmacovigilance operations: Argus workflow management, ARISg system integration, AI-assisted task automation, E2B XML conversions, PV system validation procedures, multi-site PV coordination, metrics and reporting, troubleshooting system issues, and scaling PV operations.

 

Capstone Integration

You'll complete the full pharmacovigilance lifecycle through advanced simulations: comprehensive case processing from intake to closure, building professional portfolios with documented work, interview preparation specific to PV roles, understanding emerging regulations, handling pharmacovigilance crises, and executing final capstone simulations that test all acquired competencies.

 

Systems You'll Use

Training includes hands-on work with the software and databases used in pharmaceutical safety operations:

• Safety database systems (Argus, ARISg workflow simulations)

• E2B(R3) transmission and validation tools

• MedDRA browser and coding tools

• WHO VigiBase and FDA FAERS query interfaces

• Statistical analysis tools for signal detection

• Document management and quality control systems

• AI-assisted case narrative generation and MedDRA auto-coding

• Predictive analytics and NLP systems for adverse event analysis

• PV dashboards and metrics reporting tools

• Blockchain systems for data integrity validation

AI tools are integrated throughout—you'll learn to use them as productivity multipliers, not replacements for judgment. This mirrors how modern drug safety professionals actually work.

 

Career Outcomes

Graduates are prepared for these pharmacovigilance roles:

• Drug Safety Associate / Executive

• Pharmacovigilance Case Processor

• Signal Management Analyst

• Aggregate Reporting Specialist

• Regulatory Safety Associate

• PV Operations Coordinator

• Medical Review Support

• Clinical Safety Analyst

Both multinational pharmaceutical companies and specialized contract research organizations actively recruit candidates with documented pharmacovigilance competencies. This training provides that documentation.

 

Ready to start? Enroll now and begin immediately.