,Quality Control in Pharmacovigilance - Overview
Any scientific or safety report must be composed clearly, concisely, and in full compliance with established regulatory and quality standards. Stringent Quality Control in Pharmacovigilance ensures that all clinical, nonclinical, and post-marketing safety documents are consistent, accurate, and validated under a strong Pharmacovigilance Quality Control framework. Stringent QC processes are essential for maintaining data integrity and ensuring that safety information meets both regulatory expectations and scientific rigor.
Organizations often face challenges in maintaining consistency across pharmacovigilance documentation, PV SOPs, and data verification processes within their PV System. To overcome these challenges, Freyr’s specialized Quality Assurance teams teams perform comprehensive and systemic reviews as part of an integrated Pharmacovigilance Quality Assurance framework This approach ensures that all processes and deliverables adhere to the required structure, accuracy, format, and regulatory compliance standards.
Expertise in Quality Control in Pharmacovigilance
Freyr’s medical writing and pharmacovigilance teams implement a structured and project-specific Quality Control (QC) framework to ensure accuracy, consistency and data integrity across all safety documents. Each deliverable is reviewed using a standardized checklist aligned with client-specific requirements and global regulatory quality standards.
Our independent Pharmacovigilance Quality Control Services ensure unbiased comprehensive review and validation of all safety-related submissions. This QC framework is seamlessly integrated with elements of Pharmacovigilance Quality Assurance (QA) and PV Training, enabling organizations to proactively identify and mitigate compliance gaps through periodic PV Gap Analyses, targeted training, and continuous process improvement initiatives.
Quality Control in Pharmacovigilance
- Quality Review: This step ensures all documents adhere to Pharmacovigilance Quality Assurance and Pharmacovigilance Quality Control principles. Our reviewers validate transcribed data, check structural accuracy, and ensure consistency with regulatory expectations, PV SOPs, and internal templates.
- Medical Review: Ensures clinical and medical data are accurately represented, interpreted correctly, and aligned with submission requirements. The medical reviewer acts as an authorized signatory for critical Regulatory documents, ensuring correctness and completeness of data presentation.
- Peer Review: Confirms that the scientific intent, logical flow, and regulatory context are conveyed effectively. Each document undergoes multiple layers of assessment to align with both compliance and audit-readiness standards.
- Expert Review: A domain expert ensures data accuracy, scientific soundness, and regulatory compliance. They also assess document readiness for audit, PV agreement, and supporting materials like SDEA or PVSA documentation.
- End-to-end Pharmacovigilance Quality Control Services integrated with medical writing and submission support.
- A well-trained team with Regulatory domain expertise ensures accuracy, compliance, and audit readiness across all documents.
- Streamlined PV System supported by global best practices for consistency, transparency, and data integrity.
- Support for PV Gap Analysis, and QMS improvement to strengthen your overall compliance framework.
- Efficient documentation review and delivery within reduced timelines without compromising on quality.
