As part of the PV system, the marketing authorization holder (MAH) shall have permanently and continuously at its disposal a full-time qualified person responsible for Pharmacovigilance (QPPV) resides in country of marketed product(s). The MAH shall submit the name and contact details of the QPPV to the drug regulatory authority. Changes to this information should be submitted in accordance with regulation on the regulatory authority variations guidelines. The duties of the QPPV shall be defined in a job description. The hierarchical relationship of the QPPV shall be defined in an organizational chart together with those of other managerial and supervisory staff.
Our specialties include local contact person for PV, regional PV compliance, PV training, signal detection and signal management and data management. We also provide local QPPV services for companies and CROs.
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