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Medical writing in pharmacovigilance: An overview

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Short Communication

Author Details : Abhijit Anil Trailokya*, Sunil Chaudhary

Volume : 9, Issue : 4, Year : 2024

Article Page : 293-296

https://doi.org/10.18231/j.ijcaap.2024.042

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Abstract

Medical writing is an integral part of pharmacovigilance, ensuring that safety information is communicated effectively and meets regulatory standards. Pharmacovigilance medical writing plays a crucial role in both the clinical development and post-marketing stages. It also significantly contributes to the preparation of mandatory submission documents that are essential for obtaining marketing authorization or approval from regulatory authorities. Medical writing plays a pivotal role in pharmacovigilance by crafting clear, precise, and regulatory-compliant documents that communicate safety information effectively. The field encompasses the preparation of essential documents such as Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and Periodic Adverse Drug Experience Reports (PADERs), all of which are critical for monitoring the safety and efficacy of pharmaceutical products. Medical writers in pharmacovigilance are responsible for synthesizing complex clinical data, reporting adverse events, and ensuring compliance with regulatory guidelines. This overview highlights the key responsibilities of medical writers, the regulatory frameworks governing their work, and the importance of effective communication in maintaining drug safety and patient health.

Keywords: Pharmacovigilance, Medical writing, PSUR, PADER

How to cite : Trailokya A A, Chaudhary S, Medical writing in pharmacovigilance: An overview. IP Int J Compr Adv Pharmacol 2024;9(4):293-296

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