Pharmacovigilance Auditors provide third-party verification that systems and documentation are in place and consistently followed to ensure drug safety, protect your patients and meet regulatory requirements. Third party audits also provide an opportunity to uncover issues in advance of formal regulatory inspections, which can lead to warning letters.
The World Health Organization (WHO) defines pharmacovigilance as: the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Provide audits anywhere in the world. We will identify the right auditor that is closest to the site to be audited to keep your expenses low. You can choose scheduled audits or surprise audits. We can provide the following types of Pharmacovigilance Audits
• Clinical Research Organization (CRO) GCP Audits
• Investigator/Study Site Pharmacovigilance Audits
• Vendor Pharmacovigilance Audits
• Institutional Review Board Pharmacovigilance Audits
• Pharmacovigilance Inspection Readiness
• Pharmacovigilance Audits of Phase I Units
• Responsibilities and Organization for Pharmacovigilance
• Interaction between Drug Safety and the Medical Affairs team
• Interaction between Drug Safety and Technical Quality Assurance team (Quality Complaints)
• Literature Screening
• Management of Safety related Processes in Clinical Trials
• Processing and Submission of Individual Cases
• Periodic Safety Reporting (PSUR, DSUR…)
• Signal Detection and Management
• Core Safety Information
• Maintenance of approved Product Information
• Risk Management / Pharmacovigilance Planning
• Quality Management Systems
• Validation of Computer Systems, Security, Back-up and Disaster Recovery
1. Our staff members are member leaders in ASQ, giving us a deep understanding of quality assurance, inspections and auditing.
2. Pharmacovigilance Auditors provide third-party verification to ensure compliance with regulatory bodies around the world.
3. They also ensure your trials will be completed on time and right the first time and avoids warning letters and costly regulatory follow up.
4. We promote ethos, dedication and ethical behavior across industries. Only by maintaining ethical behavior will an auditor deliver true value for the client.
5. Your PV auditors will have years of experience training, consulting and auditing diverse companies in your industry.
6. You will receive a successful, satisfying outcome. Throughout the process, you will have direct access to our CEO to address your concerns.
Interested in working with us? Reach out below.