QPPV offers Pharmacovigilance & Clinical Safety Consultancy Services, including the provision of Qualified Person for Pharmacovigilance (QPPV) and Responsible Person (RP) for Pharmacovigilance in Clinical Trials, with the necessary tools, experience and expertise to support Sponsors, Marketing Authorisation Holders and Applicants.
QPPV can act as a virtual Pharmacovigilance Department, partnering with Pharma/Biotech companies to support setting up or maintain and manage their Pharmacovigilance Systems, focusing on patient safety and adhering to regulations and guidelines, developing effective strategies and designing high quality and scalable solutions.
QPPV offers highly specialised and experienced Medical, Scientific and Strategic support throughout the life-cycle of medicinal products.
QPPV is a forward thinking company and believes in the use of technology to improve and innovate processes ensuring the safe and efficacious use of medicines.
For more information about Artificial Intelligence and how we are aiming to tackle the cost and complexity of Pharmacovigilance & Clinical Safety, please click
Nicole Baker PhD
Immunologist and Pharmacovigilance Professional with extensive knowledge in global legislation and guidelines for Medical Affairs, Regulatory Affairs, Pharmacovigilance and Clinical Trials, gained by leading and managing global, multi-disciplinary teams.
Extensive experience in providing strategic, operational and scientific leadership throughout the product life-cycle, from pre-clinical to post-marketing.
Experience gained supporting or fulfilling the role of Qualified Person for Pharmacovigilance and Responsible Person for Pharmacovigilance in Clinical Trials over the past 8 years.
Overall 20 years’ experience gained within Academia, Pharmaceutical Industry, Regulatory Authority, Clinical Research Organisation. and more recently Start-up.
Experienced Technologist and Engineering Leader with broad industry experience spanning a career of over 20 years, having performed senior engineering/engineering management roles on large scale Cloud Infrastructure, Fintech, Healthcare and Artificial Intelligence Services.
Bruno Ohana PhD
Artificial Intelligence Engineer
Senior Pharmacy Technician, with 15 years experience with direct contact with patients and very good understanding of Pharmacovigilance and Drug Safety. Recently retrained in Pharmaceutical Business Operations with emphasis in Pharmaceutical and Medical Devices manufacturing and International Regulatory Affairs.
CLINICAL SAFETY AND PHARMACOVIGILANCE CONSULTANCY SERVICES
EEA AND LOCAL QPPV SERVICES
As part of the Pharmacovigilance System, the Marketing Authorisation Holder shall have permanently and continuously at its disposal an appropriately qualified Local and EEA QPPV.
The Marketing Authorisation Holder shall ensure that the EEA QPPV has sufficient authority to influence the performance of the Quality System and the Pharmacovigilance activities of the Marketing Authorisation Holder.
The Marketing Authorisation Holder should therefore ensure that the EEA QPPV has access to the Pharmacovigilance System Master File (PSMF) as well as authority over it and is notified of any changes to it.
The authority over the Pharmacovigilance System and the PSMF should allow the EEA QPPV to implement changes to the system and to provide input into risk management plans as well as into the preparation of regulatory action in response to emerging safety concerns.
We can offer very experienced Pharmacovigilance & Clinical Safety professionals, with the capability and expertise to advise Sponsors, Marketing Authorisation Holders or Applicants.
Combined knowledge and experience to shape and transform processes and strategies improving companies' business structure.
Above all we are proud to have helped and contributed to bring, keep and maintain safe and efficacious medicinal products to the market, promoting Patient Safety.
Local or EEA QPPV and Deputy
RP for Pharmacovigilance in Clinical Trials
Interim Management Solutions
Support with Marketing Authorisation Application
Pharmacovigilance Set-up, Implementation and Development
Artificial Intelligence Systems Development and Automation
Individual Case Safety Report Management
Post Authorisation Safety or Efficacy Studies
Risk Management and Benefit Risk Analyses
Signal Detection and Management
- Aggregate Reporting
Due Diligence/Gap Analyses
Quality Management Systems