Medical Writing Risk Management Pharmacovigilance medical writing: An evolving profession
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Volume 24, Issue 2 - Risk Management

Pharmacovigilance medical writing: An evolving profession

Abstract

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting the document, coordinating the input of the involved functions, providing valuable expertise on the required format and contents and detailed guideline knowledge, and coordinating the review and consolidation of comments. Furthermore, different submission scenarios and document requirements exist, depending upon, for example, the medicinal product, therapeutic indication, and authorisation procedure. The result should always be a high-quality state-of-the-art document meeting all requirements for an electronic submission to health authorities worldwide.

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References

  1. Good pharmacovigilance practices. European Medicines Agency [cited 2015 Feb 16]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp
  2. GVP Module V – Risk management systems, EMA/838713/2011 Rev 1. European Medicines Agency and Heads of Medicines Agencies [2014 Apr 15; cited 2015 Feb 16]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
  3. GVP Module VII – Periodic safety update report (Rev 1), EMA/838713/2011 Rev 1. European Medicines Agency and Heads of Medicines Agencies [2013 Dec 9; cited 2015 Feb 16]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf
  4. EMA homepage. European Medicines Agency [cited 2015 Feb 16]. Available from: http://www.ema.europa.eu/
  5. GVP Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators, EMA/204715/2012 Rev 1. European Medicines Agency and Heads of Medicines Agencies [2014 Apr 15; cited 2015 Feb 16]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162051.pdf
  6. EMA and HMA. GVP Annex I - Definitions, EMA/876333/2011 Rev 3. European Medicines Agency and Heads of Medicines Agencies [2014 Apr 15; cited 2015 Feb 16]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143294.pdf

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President's Message
The changing face of (benefit-)risk management
Pharmacovigilance medical writing: An evolving profession
A shot at demystifying the risk management plan for medical writers
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Special section: Winners of the Geoff Hall Scholarship essay competition
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Profile: An interview with Ingrid Edsman on why attending EMWA conferences is so rewarding!
The Webscout
In the Bookstores
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Lingua Franca and Beyond
Gained in Translation
Manuscript Writing
English Grammar and Style: Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 3 - Double syntactic unit revision and syntactic position revision
Out On Our Own

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