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Solutions

Structured Content for Global Safety Reporting
That Keeps Pace with Change

Safety Writing at Scale—DSURs, PSURs & RMPs Without the Rework

Pharmacovigilance teams face rising demands to deliver consistent, compliant safety documents—fast. From DSURs and PSURs to RMPs and signal detection reports, writers must:

Reuse validated content
Maintain consistency
Ensure traceability
Meet evolving regulatory standards

But many still rely on manual Word docs and versioned folders.

Docuvera changes that.
Our structured, component-based model helps PV teams scale efficiently—reducing rework and increasing confidence.

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How Docuvera Supports Pharmacovigilance Writing

Docuvera helps safety writing teams manage cross-functional content as structured, governed components that can be reused, updated, and published with full traceability.

Modular Safety Content

Docuvera helps safety writing teams manage cross-functional content as structured, governed components that can be reused, updated, and published with full traceability

PV-Specific Templates with Embedded Logic

Configure modular templates for common report types, embedding rules that enforce structure while enabling case-specific flexibility.

Targeted Review and Approval

Assign reviewers and approvers at the component level. Reviewers can focus only on new or modified text—reducing review fatigue and speeding approval cycles.

Ready-to-Publish Output

Generate agency-ready XML and internal formats from structured content, eliminating the need for manual formatting and ensuring submission readiness.

Aligned with Global Writing and Reporting Standards

Docuvera supports modular authoring across core regulatory writing deliverables. By managing content at the component level, Docuvera enables traceable updates, global consistency, and true content reuse across PV and regulatory functions.

DSURs (Development Safety Update Reports)

Streamline annual safety updates by reusing validated pharmacovigilance content across products and geographies.

PSURs / PBRERs (Periodic Safety Update Reports)

Maintain consistency in safety narratives and signal evaluations—regardless of reporting frequency or regional variation.

RMPs (Risk Management Plans)

Author core sections of RMPs once and adapt locally without rewriting—preserving audit integrity and compliance history.

Signal Evaluation Documentation

Support consistent risk assessments with structured components for hypotheses, analyses, and conclusions—ready for reuse across safety deliverables.

Investigator’s Brochures (IBs)

Ensure aligned safety messaging by reusing validated core content across IBs, DSURs, and RMPs—reducing manual updates and review cycles.

Clinical Narratives and Summaries

Enable real-time collaboration and structured reuse across high-volume patient narratives and clinical safety summaries.

Operational Impact for Pharmacovigilance Teams

Challenge
Without Docuvera
With Docuvera

Manual reuse from prior reports

Time-consuming and inconsistent

Modular reuse of validated content across deliverables

Re-review of unchanged language

Redundant reviewer effort

Focused review of only modified or new content

Disconnected update cycles

Fragmented content and approval workflows

Centralized governance with shared content libraries

Formatting delays for submissions

Final-stage bottlenecks in formatting and QA

Submission-ready output in structured, compliant formats

Challenge

Manual reuse from prior reports

Re-review of unchanged language

Disconnected update cycles

Formatting delays for submissions

Without Docuvera

Time-consuming and inconsistent

Redundant reviewer effort

Fragmented content and approval workflows

Final-stage bottlenecks in formatting and QA

With Docuvera

Modular reuse of validated content across deliverables

Focused review of only modified or new content

Centralized governance with shared content libraries

Submission-ready output in structured, compliant formats

Why It Matters

Pharmacovigilance teams are essential to regulatory success and patient safety—but many still operate with outdated, document-centric tools. Docuvera enables safety writers to:

Reuse approved language across programs and products
Ensure consistent safety and regulatory messaging
Maintain audit-ready content histories and submission packages

As the industry transitions to content-centric processes, Docuvera gives safety writers the control, traceability, and scalability needed to lead with confidence.

Related Content:

AI-Powered Structured Content Authoring
Operational Efficiencies
Quality & SOPs
Regulatory Compliance & Risk Mitigation

Streamline pharmacovigilance and safety writing with Docuvera’s AI-Powered structured content platform. Support modular authoring for DSURs, PSURs, RMPs, and more.

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