Compliant workflow management for pharmacovigilance

Pharmacovigilance groups depend on targeted, up-to-date product information and adverse event reporting to meet regulatory requirements. However, workflows become overcomplicated due to increasing amounts of data, multiple information sources lacking integration and standardized search and alert functions. What’s more, with global teams, oversight can be challenging.

How QUOSA PV helps
Centralize discovery and review of critical adverse event information from various sources, including peer-reviewed literature databases and information from the EMA Medical Literature Monitoring (MLM) initiative. QUOSA PV is a GxP-compliant pharmacovigilance workflow management tool that streamlines database monitoring, supports document triage and review, and facilitates oversight and auditing.

QUOSA PV promotes efficiency and compliance by letting you:

  • Review literature and monitor the article pipeline from a single browser-based interface
  • Reduce review time by automatically de-duplicating search results
  • Quickly identify adverse events from a broad spectrum of sources
  • Rapidly assess information with automated literature review and triage

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  • Improve oversight and efficiency with workload management tools and dashboard views
  • Optimize the interface for your processes with flexible workflows and user roles
  • Rapidly identify case, signal and drug-specific data with a searchable database o
  • Ensure compliance with regulatory best practices and GxP-regulated environments

How QUOSA PV works

See how our workflow management tool promotes efficient and compliant pharmacovigilance. QUOSA PV helps you automate monitoring of relevant databases, streamline assessment of captured information, and more easily supervise the workflow.

Download the Fact Sheet (PDF, 271kb)

Featured customer story

Donna Sees, Information Consultant with PharmIntell Consulting, discusses post-market surveillance best practices for medical device companies and how QUOSA helps.

Read the customer story (PDF, 521kb)


Ideas and insights for industry professionals

Pharmacovigilance requires the right tools


Literature monitoring can help you report adverse events fast only if your process is up-to-date. With more data today than ever before — and more adverse events reported —monitoring has become more challenging. But the right solutions can help you.

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Balancing in-house and outsourced monitoring

A balanced approach to literature monitoring - R&D Solutions | Elsevier

Combining outsourced literature management with an in-house solution can help companies overcome search challenges by improving oversight, increasing efficiency and providing greater flexibility in managing workload.

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Learn more about Elsevier's R&D Solutions for Pharmacovigilance

Thousands of pharmacovigilance and drug safety teams at pharmaceutical companies rely on Elsevier’s R&D Solutions and services. We have focused on providing comprehensive coverage of drug safety data sources and alleviating challenges with pharmacovigilance processes. In addition to QUOSA PV, drug safety teams worldwide benefit from the support of these solutions and services.

PharmaPendium

Make more informed decisions on drug safety and efficacy, risk, and study design. PharmaPendium delivers comparative drug interaction data and facilitates searches of FDA and EMA drug approval document sources, including FAERS.

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Embase

Improve monitoring of biomedical literature for adverse events. Embase is the world’s most comprehensive database of peer-reviewed and grey biomedical literature. It includes crucial non-English content and offers unique support for search design.

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Professional Services

Let informatics and analytics experts support your drug safety goals. Our Professional Services team can streamline adverse event and safety signal detection by validating search strategies and implementing solutions for literature triage and review.

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