Qualified Person Responsible for Pharmacovigilance ((EU)-QPPV)
Our (EU-) QPPV Service is a critical component of any pharmaceutical company’s pharmacovigilance system. It ensures compliance with regulatory requirements and guidelines to monitor drug safety and implement effective risk management strategies.
Why Choose Our (EU-) QPPV Service?
Our service provides your company with cost-efficiency, expertise, and experience, all aimed at minimizing risk and ensuring product safety. We offer a comprehensive range of QPPV services tailored to meet your company’s specific needs.
Dr. Kerstin Döpfner-Ozan
Director of Pharmacovigilance & Clinical Safety, Medical Monitor
Kerstin has a scientific background as lead physician on Intensive Care Units and Anesthesiology with the organizational, diplomatic and research skills that are developed by this responsibility and are very useful in the daily departmental and scientific task management.
Her experience in drug development comprises all aspects of clinical safety and pharmacovigilance in global, large-scale, long-term clinical trials as well as PV Audit services and trial administration/ oversight tasks like EV Responsible Person and (EU-)QPPV service.
As a physician, Kerstin is also leading our team of Medical Monitors to guarantee the safety of research subjects and to help ensure the scientific reliability, clinical integrity, and quality of the clinical trial.
She is also experienced in support and presentation activities such as Investigator meetings, Safety Review committee meetings and Data Monitoring Committee meetings.
Your service expert
Dr. Kerstin Döpfner-Ozan
Director Pharmacovigilance & Clinical Safety
Our Services includes
Provision of a Full-Time or Part-Time (EU-) QPPV
A qualified expert dedicated to your pharmacovigilance, ensuring that all legal obligations are met.
Back-up (EU-) QPPV Services
A skilled backup QPPV is available to ensure continuity in pharmacovigilance operations during the absence of the primary (EU-) QPPV.
Oversight of the Pharmacovigilance System
Our QPPV ensures that your pharmacovigilance system fully complies with regulations and guidelines.
Training for Company Personnel
We offer targeted training on pharmacovigilance responsibilities and best practices to strengthen your team’s competency.
Pharmacovigilance System Master File (PSMF) Maintenance
Our (EU-) QPPV keeps your PSMF up-to-date, accurately reflecting the structure and operations of your pharmacovigilance system.
Regulatory Authority Communication
Acting as the main contact point with regulatory authorities, our (EU-) QPPV ensures effective communication on product safety matters.
Auditing and Inspection Readiness
We ensure your pharmacovigilance system is always prepared for regulatory audits and inspections.
24/7 Availability and Crisis Management
Our (EU-) QPPV is available around the clock for urgent regulatory requests or safety issues, ensuring that necessary actions are taken to protect public health.
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