Qualified Person for Pharmacovigilance (QPPV) Services

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.

• 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.

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.

• 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.