Qualified Person for Pharmacovigilance (QPPV) Services

Are you seeking a dedicated Qualified Person for Pharmacovigilance (QPPV) professional? Look no further. Here’s why our QPPV services stand out:

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Understanding the Role of a Qualified Person for Pharmacovigilance (QPPV)

A QPPV is a pivotal figure responsible for establishing and managing a Marketing Authorization Holder’s (MAH) pharmacovigilance system. This role assumes significant responsibility within the quality system, overseeing product safety issues and all pharmacovigilance activities.

Our QPPVs are equipped to handle key activities, including:

  • Serving as the central point of contact for safety or benefit-risk evaluations with Health Authorities 24/7.
  • Ensuring the Pharmacovigilance System Master File (PSMF) is regularly updated and accurately reflects the current pharmacovigilance system.
  • Monitoring the safety profiles of marketed products and addressing emerging safety concerns.
  • Ensuring all pharmacovigilance activities and document submissions adhere to local regulations.
  • Acting as the liaison point for pharmacovigilance audits or inspections.
  • Maintaining detailed records for suspected adverse reactions to marketed products.
  • Planning, drafting, and submitting Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) to national Competent Authorities.

Local Person for Pharmacovigilance (LPPV) or Local Safety Officer (LSO) Services

Whether you require an LPPV, LCPPV, or LSO, our services cater to your regional pharmacovigilance needs. Our experienced local officers ensure Pharmacovigilance compliance and enhance the quality of your drug safety operations.

Responsibilities of our LPPV/LCPPV/LSOs include:

  • Ensuring compliance of local pharmacovigilance operations with company SOPs and work instructions.
  • Managing adverse event reporting and reconciling cases with internal and external partners.
  • Reviewing local labeling changes and providing safety-related information in response to external queries.
  • Overseeing local risk mitigation measures and optimizing adverse event reporting processes.
  • Supporting the submission of reports to local authorities and maintaining inspection readiness.

Got your own Question? Here are some options:

Through our vetted and qualified network, we possess comprehensive knowledge of pharmacovigilance requirements in Africa, guaranteeing full compliance monitoring and effective local pharmacovigilance operations management.

If you need comprehensive and reliable support for your pharmacovigilance system, our team is ready to assist. Reach out to us today to discuss your specific requirements and how we can help.

Email Us: info@jeyflex.com

Learn more about how we can help you achieve compliance and success in the pharmaceutical industry.

Contact us today

Learn more about how we can help you achieve compliance and success in the pharmaceutical industry.

Service Details

Our solutions are tailored to meet your unique needs and requirements, whether you’re a small startup or a large multinational corporation. We offer a range of services, including, consulting, training, and auditing, to help you ensure that you are complying with relevant regulations and laws, and to minimize the risk of non-compliance.

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