Pharmacovigilance Medical Writing

As a specialist service provider in this area, we continue to provide leadership, plus content writing and guidance on report structure, to existing and new clients wherever needed, and have a full and broad understanding of all necessary requirements for all types of safety reports.

Please call us for a confidential discussion of your project writing needs.

For the clinical development phase:

  • DSURs
  • IND Annual Reports
  • Clinical SAE narratives

In preparation for marketing authorisation:

  • Summary of Clinical Safety (CTD Module 2.7.4)
  • Integrated Summary of Safety
  • Clinical Overviews (overview of safety)
  • EU RMPs, US REMS & associated education materials
  • Literature searches/reviews

For the post-marketing phase:

  • EU PSURs/PBRERs
  • US PADERS/PAERs
  • 120-Day Safety Update Reports
  • Clinical Overview Addenda (for type II variations; changes to EU SmPCs)
  • Safety reviews & summaries, including ad hoc reports
  • Response to Questions Documents
  • Benefit-Risk Assessment Reports
  • Safety Signal Assessment Reports
  • EU RMPs, US REMS & associated education materials
  • Literature searches/reviews



What is pharmacovigilance medical writing?

Pharmacovigilance medical writing plays a crucial role at every stage of the drug development process.

From clinical development through to the mandatory submission reports required prior to obtaining regulatory approval for marketing, pharmacovigilance medical writing is a necessary element at every stage. This requires the presence of specialised writers for successful navigation through the various sets of technical requirements.

The clinical development phase of any drug requires annual DSURs in the EU and IND Annual Reports or DSURs in the US, which are used to report on the safety of participants in clinical trials.

When submissions are made for marketing authorisation, reports analysing safety data make up a significant proportion of the submitted documentation.

After marketing authorisation is granted, pharmacovigilance medical writing specialists are needed to ensure the quality of documents such as PSUR/PBRERs, RMPs and ad-hoc safety reviews.

And of course, RMPs and Benefit-Risk Evaluation Reports continue to be updated throughout a product's life cycle, meaning the need for pharmacovigilance medical writing expertise remains constant.



Pharmacovigilance medical writing across the drug development process

Adapted from 'Pharmacovigilance Medical Writing: A Good Practice Guide' by J. Orleans-Lindsay, 2012.