Quality Control in Pharmacovigilance - Overview
Any scientific report/document must be composed in a clear, concise, and compliant way and be validated by stringent quality control in pharmacovigilance. The document must convey scientific information without any ambiguity or misrepresentation. To ensure that the documents related to clinical, nonclinical, and other areas are aligned with the industry standards and the specific PV quality management system, organizations may face difficulties in performing thorough quality assurance in pharmacovigilance of the structure, formats, Standard Operation Procedures (SOPs), grammar, authenticity, accuracy of medicinal information, the structural flow, logical interpretation, etc.
By designating project-specific reviewers, Freyr undergoes a rigorous medical writing and pharmacovigilance review process to help organizations develop high-quality documentation. Our medical writing pharmacovigilance and medical affairs services follow a robust method where every document has its own Quality Control (QC) process map and checklist to ensure that the document reaching the client is of utmost quality in terms of scientific, language, grammar, and format, and is submission ready. Freyr deploys an independent quality control/review team that is not part of the core medical writing pharmacovigilance team to avoid bias.
Quality Control in Pharmacovigilance
Quality Review
This review ensures that the document is prepared with pharmacovigilance quality assurance in terms of transcribing information from the source documents, the correctness of the data structure, diligently following a relevant style guide, SOPs, and template, formatted correctly, and is grammatically correct.
Medical Review
This review ensures the document is medically and clinically interpreted correctly without missing any medical information from the source document. The medical reviewer would be the authorized signatory for some of the Regulatory documents to ensure that the data/information presented in the document is correct.
Peer Review
This review ensures that the concept is covered appropriately with the proper flow in the document, the information is presented correctly, and the overall document conveys the scientific and logical purpose and intent.
Expert Review
A domain expert performs this review. The reviewer looks at the scientific correctness of the data generated, presented, and interpreted in the documents and would be the authorized signatory of some of the Regulatory documents to ensure the data/information presented is correct.
- Robust medical writing in pharmacovigilance with a detailed and precise process map & checklist for delivering submission-ready documents to the client.
- A well-experienced quality control team with Regulatory domain expertise ensures a thorough quality check of the documents within reduced timeframes.
