Pharmacovigilance

Aggregate Safety Reporting: DSUR, PBRER and PSUR

Aggregate safety reports communicate benefit-risk understanding across the product lifecycle. Viltis supports planning, authoring coordination, data tables strategy, and QC for DSUR, PBRER, and PSUR d…

Discuss this serviceSchedule a call
Practice areaPharmacovigilance
Typical needCapability support for regulated programs
EngagementConsulting, augmentation, or hybrid
Related pathPharmacovigilance

The client situation

When organizations typically need this capability.
  • Report calendar pressure
  • Quality issues in prior aggregate reports
  • New product launch reporting needs

How Viltis helps

Structured support, end to end

  1. 01

    Step 1

    Timeline and RACI planning

  2. 02

    Step 2

    Authoring and medical review support

  3. 03

    Step 3

    Signal integration into narratives

  4. 04

    Step 4

    QC and inspection readiness of reports

Aggregate safety reports communicate benefit-risk understanding across the product lifecycle. Viltis supports planning, authoring coordination, data tables strategy, and QC for DSUR, PBRER, and PSUR deliverables.

Typical deliverables

What engagement can produce

Project plans

Draft and final report packages

Lessons-learned memos

FAQ

Common questions

Do you write full medical narratives?

We provide medical writers and safety scientists who work with your QPPV / safety leadership under clear ownership models.

Related proof

Manufacturing, Quality and Process Team

Recommissioning and qualifying a manufacturing site to produce COVID-19 test kits at scale.

Read the case study →

Viltis provides consulting and resourcing for compliance readiness and operational support. We do not issue certifications or act as an accredited certification body.

Need support with Aggregate Safety Reporting: DSUR, PBRER and PSUR?

Discuss this requirement with our team - scope, timeline, and delivery model.

Schedule a consultationContact us