Volume 24, Issue 2 - Risk Management
Pharmacovigilance medical writing: An evolving profession
Authors: Tiziana von Bruchhausen, Kerstin Prechtel
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
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