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Essentials of Safety Medical Writing

Everything you need to know to effectively write safety reports.


Good writing begins with good planning, whether you are at the beginning of clinical development or working on an approved medicine. In recent years, there has been an increasing demand for regulatory documents focusing on patient safety. The requirements for safety reporting are similar worldwide and share the necessity for the writer to effectively distill the risk and benefits of the medicinal product. To successfully manage these reports, safety medical writers must be able to understand the principal scope of the pharmacovigilance (PV) documents that are relevant during the medicinal product lifecycle. Equally important to delivering a succinct summary is effective collaboration with safety professionals, which requires special consideration and analysis of the data to clearly communicate the key messages and findings for a given report.

This on-demand training course takes an average of 6.5 hours to complete. Learners have access to the course for one year from the date of purchase.


    • Overview of pharmacovigilance document
    • The DSUR
    • Submission
    • The Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS)
    • Periodic post-marketing safety reporting (PBRER/PSUR/PADER)
    • Safety writing skills


  • This course is designed for professionals working in:

    • Drug safety/pharmacovigilance in R&D, post-market
    • Safety risk assessment, benefit-risk assessment
    • Risk communication
    • Medical writing
    • Aggregate reports writing team
    • Medical communications
    • Clinical/medical
    • Clinical informatics, data science, and statistics
    • Epidemiology
    • Regulatory affairs
    • Product labeling
    • 学習目的

      • At the conclusion of this activity, participants should be able to:

        • Explain the basic principles of key pharmacovigilance documents
        • Identify the relevant data sources and focus on key messages relevant for each report
        • Develop key messages based on data review
        • Create reports that meet the needs of your audience