JAIVIK Platform
jaivik

Agentic AI Platform

JAIVIK — Intelligence That Executes

Purpose-built for Life Sciences · Natively aligned with Veeva Vault

Veeva EU Summit · Copenhagen 2026
5+
AI Assistants in current release
3
Agent portfolios — Ops, Safety & Data
GxP & 21 CFR
Part 11 compliant audit trails

Core platform positioning

JAIVIK doesn't just advise — it acts on your behalf, inside Veeva Vault and beyond, keeping your team in full control at every decision point.

Domains

  • Safety
  • Regulatory
  • Quality
  • Clinical
  • Medical
  • Commercial

Integrations

  • Veeva
  • JIRA
  • ServiceNow
  • Microsoft ADO

How JAIVIK is built

Governed. Grounded. Integration-First.

Every layer purpose-designed for GxP enterprise environments

Platform Architecture

Business Process Automation

Auto-PSUR, Safety Triage, Medical Review

Agent Orchestration

Coordinates assistants, tools & memory

Knowledge-Grounded RAG

Project KB · Org KB · Domain KB

COTS Connectors

Veeva Vault, and other systems

AI TrustGate

Governance, guardrails, LLM routing, audit

Human-in-the-Loop

Review · Approve · Full trace at every step

Design principle

Integration-first, plug-in platform — enhances Veeva, JIRA, ServiceNow. Augments existing investments, never replaces them.

Productivity boosting

Intake → Review → Submission

AI handles 80–90% of effort · Humans review and approve

Pharmacovigilance Agents

  1. Case Intake

    PDF, XML, MedWatch

  2. Medical Review

    Narrative + AE analysis

  3. Distribution

    Regulatory rules

  4. Submission

    Prepared in Vault

1

Case Generator (Intake)

Converts PDFs, XML, MedWatch, emails → structured case reports. Eliminates manual data entry.

Auto-structured
2

Medical Review Assistant

Generates full case narrative, AE analysis, regulatory impact. Supports feedback-driven regeneration.

AI-drafted
3

Case Distribution Assistant

Evaluates against regulatory rules and timelines. Auto-prioritises and prepares submissions in Vault.

Rule-driven

Release & operations

Validation Planning in Minutes, Not Weeks

GxP-compliant · Evidence captured in real time · Always audit-ready

System Enabling Agents
1

Auto Test Planner — Release Validation

Upload Release Impact Assessment → auto-creates validation scenarios, JIRA tasks, test coverage maps and traceability matrix.

End-to-end
2

Auto Test Assistant — Execution

Generates test scripts, synthesises test data, executes in sandbox, captures evidence logs and screenshots automatically.

Automated
3

Service Assistant — L1/L2 Support

Reads support tickets, suggests resolution steps, executes config actions after human approval. Reuses knowledge from prior tickets.

Knowledge-driven

Outcome

End-to-end validation lifecycle automated. Standardised test generation. Faster ticket resolution through knowledge reuse.

Natural language access

Ask Your Data in Plain English

No SQL · No data experts · Data stays within the enterprise

Safety Data Co-Pilot

RAG-powered enterprise AI

Connects to your data lakes and Veeva documents. Ask in plain English — SQL executes behind the scenes, results summarised instantly. Data never leaves your enterprise boundary.

NL Query

Data Co-Pilot converts natural language to SQL, queries enterprise safety data lake

Instant Insight
Documents

KB Curator ingests SOPs, case files, Veeva content → conversational Q&A and context-aware summaries

Smart Search
Web Content

External regulatory guidance and literature curated into a searchable, queryable knowledge base

Context-aware

Governance & compliance

Audit-Ready by Design, Not Bolted On

21 CFR Part 11 traceability · Every action captured and reportable

AI TrustGate

LLM Routing

Right model per task — cost, policy & performance

Guardrails

Prevents unsafe or non-compliant AI outputs

Audit Logging

Every create, update, approve, reject captured

Access Control

Role & attribute-based policies across assistants

Policy Engine

Enterprise & responsible AI policies at runtime

Observability

Usage tracking, monitoring & dashboards

21 CFR Part 11 traceability

Every record-related action — create, update, approve, reject, export — captured securely and available for reporting, dashboards, and audit-time investigations in real time. No separate audit prep needed.

The differentiator

Execution, Not Advice. Control, Not Black Box.

Agentic AI that acts · Governed AI that stays compliant

Why JAIVIK

Generic AI: "Here's what you should do"

JAIVIK: "Done — please review and approve"

Weeks of manual validation planning

End-to-end validation ready in minutes

SQL experts needed for safety data insights

Ask in plain English — get answers instantly

Separate audit prep before inspections

Evidence captured in real time, always ready

Find jaivik at Veeva EU Summit · Copenhagen 2026 — Stop by for a live demo. See JAIVIK execute in Vault, end-to-end.

Safety surveillance & intelligence

Earlier Insight, Defensible Decisions

Works alongside existing safety systems · AI assists, humans decide

Safety Intelligence Agents

  1. Data Harmonisation

    Multi-source, MedDRA-aligned

  2. Safety Surveillance

    Ranked with confidence score

  3. Risk Assessment

    Assessment report drafts

  4. Aggregate Reports

    PSUR · PBRER · DSUR

1

Safety Data Harmonisation Agent

Unifies safety, clinical, real-world and literature data. MedDRA-aligned, case-normalised.

Unified view
2

Safety Surveillance Agent

Continuous trend and pattern analysis. Surfaces emerging risks with a confidence score.

ML-prioritised
3

Risk Assessment Assistant

Drafts validation and assessment reports on an EMA GVP-aligned flow. Humans decide.

Human-approved

Structured risk management

From Surveillance to Decision, Documented

EMA GVP-aligned · Your experts decide at every step

Surveillance Workflow

1 · Safety Surveillance

Continuous analysis for new or changing risks

2 · Validation

Confirm relevance against set criteria

3 · Risk Assessment

Causality and clinical relevance, expert-led

4 · Communication

Timely decisions to teams and authorities

Governance Modules

Authority requests, meetings, deviations

Dictionaries & Analysis

MedDRA, IMDRF, libraries, case analysis

Built into every step

Evidence attachment · Multi-user assessment · Status tracking · Decision logging · Audit trail. Safety experts sign off each decision.

Aggregate reporting & decision support

Reports Drafted, Benefit–Risk in View

Traceable outputs · Evidence-linked insights · Human review at every step

Reporting & Insight Agents
1

Aggregate Report Assistant

Drafts PSUR / PBRER / DSUR sections from harmonised data, with full traceability for inspections.

Traceable
2

Benefit–Risk Insights Agent

Brings trial, real-world and spontaneous-report evidence into one view for benefit–risk review.

Evidence-linked
3

Safety Operations Insights

Tracks case-to-assessment timelines, review workload and bottlenecks, so teams can see where to act next.

Actionable

Outcome

Earlier risk visibility, faster assessments and inspection-ready records, governed and audit-logged by AI TrustGate.

Product strategy

From Reactive to Predictive Intelligence

Compliance-driven → Insight-driven · AI assists, humans decide

Product Strategy

Strategic direction

Pharmacovigilance is moving from compliance-driven to intelligence-driven. JAIVIK agents give teams early insight, faster decisions and defensible outcomes at enterprise scale.

GenAI

GenAI-assisted assessments: draft assessments and summarise complex evidence, speeding review with human oversight.

Assisted review
RWE

Enhanced real-world evidence integration: claims data, electronic health records and patient registries for fuller safety intelligence.

Richer evidence
Predictive

Predictive safety insights: advanced models that forecast potential risks before they emerge, for proactive planning.

Proactive