AI-Powered Pharmacovigilance

Overview

Zensar's Pharmacovigilance (PV) practice combines deep safety-domain expertise with PharmaVigil, our purpose-built automation platform, to provide life sciences and pharmaceutical organizations with a single, connected way to run compliant, scalable drug safety operations end to end.

Capabilities at a glance

Consulting

Pharmacovigilance roadmap exercises, system assessments, audit readiness assessments.

Implementation

Installation, system configuration, functional testing.

Integration

Case intake integration, data mapping, connectivity testing, error monitoring.

Data migration

Scope definition, data mapping, data profiling, dry run.

Maintenance and support

Change management, application maintenance, user support, periodic review.

AI transformation

Modernize end-to-end Pharmacovigilance with intelligent automation and next-gen AI for scalability.

Zensar's Pharmacovigilance Services connects every stage of the safety case lifecycle, from case intake to regulatory submission.

Zensar's Pharmacovigilance capabilities span the full spectrum of drug safety operations, delivering a seamless framework for case management, medical review, safety surveillance, reporting, and regulatory compliance. Backed by deep domain expertise and operational excellence, our services help organizations improve quality, shorten processing timelines, strengthen compliance, and drive better patient safety outcomes across the pharmacovigilance ecosystem.

About the tool: Zensar's PharmaVigil

At the core of PharmaVigil is an AI-powered digital case processor, trained on domain and process knowledge. It understands and interprets unstructured free text and most ADR forms, draws inferences from multiple information sources, and offers multiple case-intake channels via a cognitive avatar, automating safety-database entry and surfacing operational and performance insights.

Transformation through PharmaVigil

Challenge: Underreporting and incomplete safety data

Our solution: Multi-channel automated intake: PharmaVigil streamlines safety surveillance by capturing cases from multiple sources for timely detection, assessment, and reporting of safety events.

Challenge: Delayed and non-compliant reporting

Our solution: Structured DSUR/PSUR/PBRER workflows: Standardized aggregate reporting workflows and electronic submissions to global authorities (EMA, MHRA, FDA) keep every filing on schedule.

Challenge: Manual, labor-intensive case processing

Our solution: End-to-end case automation: Automated de-duplication, triage, MedDRA coding, causality and seriousness assessment, and narrative generation cut manual effort across the case lifecycle.

Challenge: Data volume explosion and fragmentation

Our solution: Unified integration layer: By integrating with customer third-party applications, enterprise reports, email servers, and active directory, we consolidate fragmented data into one governed pipeline.

Challenge: Poor data quality and integrity issues

Our solution: Centralized safety database: A single safety database that tracks rejected/invalid cases, along with dedicated data migration services (scope definition, mapping, profiling, and dry run), ensures clean, audit-ready data.

Solution capabilities

Intelligent ICSR case processing

Interpret unstructured free text and ADR forms, draw inferences from multiple information sources, and support multi-channel case intake. Automated activities include receipt, book-in, validity checks, triage, duplicate detection, seriousness determination, ADR inference, coding, and safety-database entry.

Integration and operational enablement

Support multiple intake formats and channels, including email, portals, ADR forms, and structured exchanges, alongside human-review portals for case review, QC, validity checks, work routing, monitoring, follow-ups, and closure.

Automated ICSR tasks

Case receipt, acknowledgment, and book-in
Validity, triage, and duplicate checks
Serious/non-serious/SUSAR determination
Automated ADR inferencing and coding
Data entry into Argus

Smart portals for human review

Case review and QC portal
Validity checks
Work routing and monitoring
Single window of processing
Follow-ups and closures

Benefits

99.99%

QC accuracy
Reduce manual quality-assurance effort and errors.

60%

faster processing
Automate triage, review, and safety-database entry.

30%-40%

OPEX savings
Minimize repetitive work and case-handling costs.

Faster

risk identification
Detect emerging drug-safety signals before escalation.

How PharmaVigil supports the safety workflow

Case intake

Book-in

Validation and triage

Inference and processing

Human review and QC

Safety-database entry

Medical review

Analysis and submission

Why choose Zensar?

Zensar stands apart by offering both deep Pharmacovigilance expertise and the PharmaVigil platform under one roof. From consulting and case processing to compliance, automation, and modernization, we deliver an end-to-end Pharmacovigilance ecosystem powered by expert services and intelligent technology. This unified approach provides a single accountable partner, enabling organizations to streamline operations, strengthen compliance, accelerate innovation, and maximize value across the drug safety lifecycle.

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