Quality Control in Pharmacovigilance - Overview

Any scientific report/document should be composed in a clear, concise, and compliant way and be validated by stringent quality control in Pharmacovigilance. It should 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 Pharmacovigilance review process to help organizations develop high quality documentation. Freyr’s Medical Writing Pharmacovigilance and medical affairs services follow a robust method where every document has its 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 a part of the core Medical Writing Pharmacovigilance team to avoid bias.