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Pharmacovigilance,
Simplified

A unified platform to automate literature screening, case detection,
and reporting built for modern life sciences organisations.

Intelligent Automation & Scalability

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Accelerate workflows, handle increasing volumes, and focus on critical decisions.

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Enhanced Accuracy & Compliance

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Ensure regulatory adherence with AI-driven analysis and full traceability.

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Seamless Data Integration

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Unifies safety data sources for proactive, comprehensive risk analysis.

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Challenges in Pharmacovigilance

Pharmacovigilance teams face growing operational, regulatory, and technological pressures. Manual processes, delayed case detection, and fragmented data management slow workflows, increase errors, and elevate compliance risks.

Manual Literature Screening

Time-consuming, prone to oversight, and slows case processing.

Delayed ICSR Detection

Critical safety signals may be missed, jeopardising patient safety.

challenges
Fragmented Data Sources

Multiple, disconnected systems impede analysis and decision-making.

Operational Strain

Teams spend excessive time on repetitive tasks rather than strategic review.

Consequences: Reduced efficiency, higher operational costs, increased compliance risks, and potential threats to patient safety.

AI-Driven
Pharmacovigilance

NovaVigil converts complex, manual literature workflows into automated, streamlined processes. With advanced AI, secure integrations, and centralised management, teams gain accuracy, transparency, and scalability.

Intelligent Literature Screening

Manual review is slow and error-prone. NovaVigil automates detection, extraction, and case structuring, reducing processing time from approximately three hours to under one.

KEY FEATURES

AI-Powered Screening & Prioritisation

Automatically identify relevant literature with precision, ensuring no critical signal is missed.

Automated Data Extraction & Case Structuring

Capture, organise, and structure safety data efficiently for faster case processing.

Contextual Analysis Guided by Domain Expertise

Combine AI intelligence with expert context for accurate and compliant case evaluation.

Real-Time Tracking of Review Progress

Monitor every screening step live, improving transparency and team visibility.

BENEFITS

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Faster Case Identification and Regulatory Reporting

Automate literature review to detect safety signals quickly and accelerate case submission timelines.

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Improved Accuracy and Reduced Human Error

Leverage AI-driven analysis to ensure precision, consistency, and compliance in every screening process.

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Increased Team Efficiency and Focus on Critical Decisions

Free teams from repetitive review tasks, enabling greater focus on high-impact, strategic pharmacovigilance activities.

Scalable Workflow Management

NovaVigil handles fluctuations in literature volume without compromising compliance or quality,
ensuring your team stays ahead regardless of workload intensity.

KEY FEATURES

Flexible Workflow Design for Varying Workloads

Adapt seamlessly to fluctuating literature volumes with configurable workflows.

Automated Task Assignment and Prioritisation

Distribute work intelligently to maintain efficiency and meet critical timelines.

Integration with Global and Local Literature Sources

Consolidate worldwide literature feeds for comprehensive coverage and compliance.

Centralised Dashboards for Oversight and Reporting

Gain complete visibility into performance metrics, progress, and compliance status.

BENEFITS

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Seamless adaptation to peak periods without additional headcount

Handle fluctuating literature volumes effortlessly with flexible, scalable workflows that maintain performance without extra resources.

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Optimised resource allocation and reduced operational bottlenecks

Distribute workloads intelligently to maximise team efficiency and eliminate process slowdowns.

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Consistent processing times and SLA compliance across all volume levels

Ensure predictable, compliant performance through automation and standardised workflow management.

Comprehensive Data &
Compliance Control

Ensure transparency, accountability, and audit readiness throughout
the pharmacovigilance process with complete oversight and traceability.

KEY FEATURES

Full Traceability of every screening and case step

Ensure end-to-end accountability with complete audit trails for all activities.

Multi-Lingual Support for non-English literature

Ensure end-to-end accountability with complete audit trails for all activities.

Secure Data Integration across systems and sources

Unify disparate safety data into one secure, compliant environment.

AI-Driven Alerts to Highlight Potential Compliance Risks

Detect anomalies early and act quickly to prevent compliance breaches.

BENEFITS

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Inspection-ready audit trails that demonstrate regulatory compliance

Maintain full traceability of every action with detailed records, ensuring effortless audit readiness and transparency.

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Reduced risk of data integrity issues and compliance violations

Safeguard processes with AI-enabled validation and secure data handling that minimise human error and regulatory risk.

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Faster response to regulatory queries with complete documentation

Access comprehensive, organised reports instantly to support timely and confident communication with authorities.

The Value We Deliver

NovaVigil empowers pharmacovigilance teams to work smarter, ensuring patient
safety, regulatory excellence, and operational efficiency—bringing AI to life in life sciences.

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Accelerated Processing

Reduce literature review time while maintaining accuracy.

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Enhanced Compliance

Fully traceable and audit-ready processes.

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Scalable & Flexible

Handle growing volumes without additional resources.

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Improve Productivity

Automate repetitive tasks to reduce time spent on redundant activities.

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Future-Ready

AI-driven insights for continuous innovation in pharmacovigilance.

Transform Pharmacovigilance with
Intelligent Automation

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