Qualified Person for Pharmacovigilance (QPPV) Services

A QPPV is an individual appointed by a Marketing Authorization Holder (MAH) as the main person responsible for ensuring that the company (the MAH) meets its legal obligations for monitoring the safety and quality of the product marketed in the country.

They ensure compliance with regulatory requirements, monitor the safety of medicinal products, and leads to the identification, assessment, and management of risks related to drug safety. In addition  QPPVs act  as a key point of contact for health authorities, providing them with safety data and ensuring timely reporting of adverse events.

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

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.

1.Ensuring compliance of local pharmacovigilance operations with company SOPs and work instructions.

2.Managing adverse event reporting and reconciling cases with internal and external partners.

3.Supporting the submission of reports to local authorities and maintaining inspection readiness.

4.Overseeing local risk mitigation measures and optimizing adverse event reporting processes.

5.Reviewing local labeling changes and providing safety-related information in response to external queries.