What is e-PV?
Electronic pharmacovigilance (e-PV) refers to the use of digital tools and platforms to collect, manage, analyze, and share information about adverse drug reactions (ADRs) and other medicine safety data. Instead of stacks of paper forms, e-PV systems use structured electronic case report forms, standardized coding such as MedDRA, secure databases, and automated workflows that accelerate reporting, triage, and signal detection.
For Marketing Authorization Holders (MAHs), regulators, and healthcare providers, e-PV transforms scattered, delayed information into timely, actionable intelligence.
Why move from paper to digital
The shift to e-PV is practical and urgent.
- Faster reporting and processing. Electronic forms reduce transcription delays and human error so safety teams receive cases sooner.
- Improved data quality. Built-in validation and mandatory fields ensure essential details such as batch numbers and dosing are captured.
- Better signal detection. Digital aggregation and analytics reveal patterns humans might miss.
- Scalability and traceability. Cloud-based systems handle tens of thousands of reports with clear audit trails for inspections.
- Regulatory alignment. Many regulators now expect E2B-compliant electronic submissions for Individual Case Safety Reports (ICSRs).
In short, faster, cleaner data leads to quicker decisions and stronger patient safety.
A real-world example: e-PV saving weeks
At a district hospital, paper ADR forms often piled up on desks and nurses struggled to complete them fully. After adopting a mobile reporting app, a nurse named Miriam submitted a case of severe vomiting in a newborn within hours of vaccination. The case automatically reached the national PV centre and the vaccine manufacturer. Within 48 hours, similar reports from other clinics were linked, revealing a cold-chain breach. A targeted recall prevented further cases.
Miriam’s timely digital report cut response time from weeks to days, showing how e-PV directly saves lives.
Where e-PV is used today
Digital PV has been standard for years in high-income countries. EMA’s EudraVigilance, FDA’s FAERS, and global databases like VigiBase rely on electronic submissions. Across Africa, adoption is accelerating. National PV centres, hospitals, and pharmaceutical companies are piloting mobile apps, cloud-based case management platforms, and regional data hubs. The African Medicines Agency and other regional initiatives are promoting interoperable, standards-based e-PV tools to enable harmonized and faster cross-border safety actions.
How e-PV works: the digital workflow
- Capture. Clinicians, patients, or MAHs log adverse events via web portals, mobile apps, or EHR integrations.
- Validate and code. Systems enforce required fields and map symptoms to standardized terms such as MedDRA.
- Triage. Automated rules prioritize serious events and assign them to case handlers.
- Follow-up. Outstanding information requests, lab reports, and correspondence are tracked in one place.
- Aggregate and analyze. Dashboards and algorithms detect unusual clusters or potential signals.
- Share and act. E2B-compliant exports and APIs securely connect to regulators, WHO databases, and MAH safety teams.
This workflow replaces manual handoffs and paper archives with speed, transparency, and measurable audit trails.
Essential features of a robust e-PV system
- E2B compatibility for international case exchange
- MedDRA and WHO Drug Dictionary coding support
- Mobile and offline reporting for low-connectivity regions
- Role-based access control and secure encryption
- Automated workflows and escalation rules
- Integrated literature monitoring and aggregate reporting tools
- Audit trails, versioning, and inspection-ready documentation
- Analytics dashboards and signal-detection modules
These features reduce risk, improve compliance, and make PV teams more effective.
Challenges slowing e-PV adoption
- Infrastructure gaps. Limited internet or unreliable power.
- Human factors. Resistance to change, training needs, and staff shortages.
- Data privacy and legal concerns. Cross-border sharing must comply with local laws.
- Costs. Setup and licensing can be significant for smaller MAHs.
- Integration complexity. Connecting e-PV to EHRs, lab systems, and regulatory portals.
Mitigation strategies include offline-capable apps, phased rollouts, regional hubs, and targeted training programs.
A practical roadmap for MAHs and regulators
- Evaluate needs. Map existing PV processes and gaps.
- Choose standards-compliant tools. E2B, MedDRA, and secure APIs.
- Pilot locally. Test workflows with one hospital or product line.
- Scale and integrate. Connect to national PV centres, EHRs, and supply-chain data.
- Measure impact. Track time-to-report, completeness, and signal-detection lead times.
- Iterate. Refine forms, validation rules, and escalation thresholds based on analytics and feedback.
FAQ: Common e-PV questions
Will e-PV replace human reviewers?
No. e-PV automates intake and triage, but expert clinical review is essential for causality assessment and regulatory decisions.
How does e-PV protect patient privacy?
Modern platforms use encryption, role-based access, data anonymization, and compliance with local data residency rules.
Can small MAHs afford e-PV?
Cloud-based subscriptions, shared regional hubs, and vendor-supported pilots make adoption possible without large upfront costs.
What standards should I insist on?
E2B for case exchange, MedDRA for coding, and secure API support for integrations are essential.
People, not just technology, drive success
Systems succeed when users adopt them. Training programs with practical use cases, short refreshers, hands-on simulations, and recognition for timely reporting improve uptake. Embedding PV into routine clinical workflows and cultivating a culture of safety, where reporting is constructive, is one of the most important investments.
Why IntraHub Africa recommends a digital-first PV strategy
Transitioning from paper to digital is not just modernization; it is a patient-safety imperative. Faster reports, better data, and powerful analytics lead to better decisions. IntraHub Africa helps MAHs, healthcare institutions, and regulators design, deploy, and scale e-PV systems that are standards-compliant, inspection-ready, and optimized for low-resource settings.
We combine technology, training, and regulatory expertise to ensure your pharmacovigilance works when it matters most.
Introducing IntraVigi™ Safety Database
Our proprietary IntraVigi™ Safety Database is a fully digital PV platform designed for the African context. It enables:
- Efficient case capture and management
- E2B-compliant reporting to regulators and global databases
- Integrated analytics dashboards
- Secure, role-based access with full audit trails
With IntraVigi™, every report is actionable, traceable, and inspection-ready, helping MAHs and healthcare institutions respond faster, ensure compliance, and protect patient safety.
Ready to modernize your PV operations, accelerate signal detection, and leverage the power of IntraVigi™?
Contact IntraHub Africa today. Let us make every report count.