Drug safety monitoring and pharmacovigilance

An essential aspect of drug development and lifecycle management is systematically screening the international literature landscape for adverse events. Embase helps you track adverse drug reactions in an auditable manner and meet regulatory requirements. Capturing potential and unanticipated side effects better informs risk-benefit assessments and safety profile optimization.

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Compliant pharmacovigilance with the PV wizard

Track all published biomedical information about your product using Embase’s PV wizard. Quickly detect and report on safety risks, side effects and adverse drug events.

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~800,000
new articles are published per year in medicine and pharmacology.

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Only 5% will be relevant for individual case safety reports

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Less than 1% will contain safety signals needed for risk-benefit assessments

The PV wizard in Embase can help you quickly create searches with 100% recall and a high degree of precision. Developed with leading industry partners, it drastically simplifies the search process by structuring the framework in 5 key sections.

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Effective risk-benefit assessment in 5 steps

Construct search strings that detect real safety signals. Monitor search results and disseminate that information to stakeholders.

Make Embase a key element in taking these 5 steps toward efficient risk-benefit assessment:

  1. Establish a pipeline of comprehensive and high-quality data from a range of sources.
    Updated daily, Embase captures a broad and relevant information landscape to monitor.
  2. Capture in your strategy the regulatory requirements of a range of authorities.
    Embase is recommended as a reliable information source by numerous agencies.
  3. Monitor local language journals in countries where a product has marketing authorization.
    Embase can help you align local and global pharmacovigilance workflows.
  4. Integrate data from the EMA Medical Literature Monitoring Service.
    MLM searches are available within Embase as part of the PV wizard.
  5. Implement a systematic monitoring approach that is ready for inspections and audits.
    Embase supports systematic searches, alerts, and numerous options for auditing.

Embase: the foundation for effective pharmacovigilance

Content

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Depend on reputable sources through >37.2 million records covering 8,100 journals and 3.6 million conference abstracts

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Get comprehensive coverage with synonyms for >33,000 drugs, plus unique non-English content

Indexing

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Find relevant content via tree-level indexing of full-text articles, including key subheadings and linked terms

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Connect concepts with direct linking of drug, disease and medical devices to events mentioned in an article

Experience

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Quickly create advanced search strings with PV wizard, a strategic tool developed together with pharma experts

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Streamline surveillance and documentation with automated searches, alerts and auditable email logs

Researcher using literature monitoring for search strategies

Build better pharmacovigilance workflows

Create effective pv workflows by solving the challenges of literature monitoring:

  • Account for local-language journals
  • Meet regional and global regulatory requirements
  • Capture all relevant adverse events
  • Eliminate anything irrelevant

Did you know?

With Embase, you can align the monitoring of local-language journals for adverse drug reactions with global pharmacovigilance workflows.

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