QPPV / LPPV / PvOI Support
The Qualified Persons Responsible for Pharmacovigilance (QPPV) or Pharmacovigilance Officer In-charge (PvOI), along with the backup QPPV / PvOI is the primary responsible person to ensure the Pharmacovigilance System and set-up of your pharmacovigilance process in accordance with the local legislation.
The QPPV / PvOI shall acts as a single pharmacovigilance contact point between the Company and Competent authority on a 24-hour basis and as a contact point for pharmacovigilance inspections. They shall reside within the EU / UK / India / any other local region as per local legislation.
- To have an overview of medicinal product safety profiles and any emerging safety concerns.
- To have an awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products.
- To have an awareness of risk minimisation measures.
- To ensure the conduct and compliance of pharmacovigilance activities as per legal requirements and
- To be an interface between the MAH Company and Competent Authorities in case of any emerging safety issues and safety concerns.
The QPPV / PvOI may delegate specific tasks to the qualified and trained individuals with a proper documentation for respective delegation. In this situation, QPPV / PvOI shall keep a complete oversight on the process and should be aware of safety profile for all authorised medicinal products.
Local QPPV, Local Contact Person, Local Responsible Person, and National Contact Person for Pharmacovigilance:
In accordance with the local regulatory mandates, certain countries may necessitate the presence of a local contact person or a locally qualified individual alongside the QPPV. Their obligations mirror those of the QPPV but are confined to the specific geographical area.
AllyWorth has a well-established network to outsource the QPPV / Local QPPV services, for EU / UK / any other country worldwide, where it requires for marketing authorisation holder to appoint the QPPV / Local QPPV as per local requirement.