A Qualified Person for Pharmacovigilance (QPPV) and a deputy of QPPV are appointed on behalf of your company. In countries other than Turkey, in accordance with local authority guidelines and regulations, QPPV and deputy of QPPV is appointed based on your needs.
Appointment of Qualified Person for Pharmacovigilance (QPPV)
Adverse Reaction and MedDRA Coding Management
Our team is responsible for receiving and evaluating adverse reaction notifications from different sources, and for MedDRA coding, monitoring, archiving of those notifications and, if necessary, submitting them to the authority.
DeltaPV provides a national, international and country-specific literature search in local journals weekly on a regular basis in accordance with your request and in case of need, retrospectively through LITSIS (literature search system), and shares the results with your special username and password.
Security Alerts Scan
Web sites of the authorities of different countries are scanned daily. If there is an important/emerging safety warning relating to one of your medicinal products, you will be informed immediately.
Management of Periodic Benefit Risk Evaluation Reports (PRBER)
In accordance with the Periodic Benefit / Risk Evaluation Report guideline, the dates of your reports are determined, prepared in a short time and submitted on time.
Risk Management Plan (RMP) Management
In case of need, the Risk Management Plan is prepared in a short time and submitted in a timely manner in line with the Risk Management Systems guideline.
Pharmacovigilance System Master File (PSMF) Management
The PSMF is a legal requirement demanded by the authorities from license / authorization holders. PSMF should contain all the information that identifies your pharmacovigilance system and should provide access to internationally available safety information for your licensed medicines. The DeltaPV team provides the support you need to prepare and / or keep your PSMF up-to-date in all countries where you operate, in accordance with current regulations and guidelines.
Dear Healthcare Professional Letters
Dear Healthcare Professional Letters are prepared by DeltaPV to be communicated to the healthcare professionals upon obtaining the ministry’s approval, consultancy is provided for its distribution and a closing report can be written by our team.
Pharmacovigilance training can be provided upon your request either to all your staff or only to your pharmacovigilance unit. The training is provided by the QPPV and / or his/her deputy, who is appointed on behalf of your company. Training content and length are tailored to your needs and the material is prepared accordingly. The training can also be provided over the Internet or face to face, to small or large groups again as per your request.
SOP Preparation and Management
Support is provided for the writing, update and storage of your pharmacovigilance SOPs according to your needs.
VigidataPV is a MedDRA compatible pharmacovigilance database software with secure archive, data backup and recall features, and with an alarm system, a username and password specially created for you, that you can personalize according to your needs
As per your request, if your archive is stored in DeltaPV, the ministerial inspections and audits can be carried out in DeltaPV offices. If the inspection/audit is carried out in your company, DeltaPV can assist you for audit preparation with mock audit and consultancy. Also, pharmacovigilance officer and his/her deputy appointed by DeltaPV for you can come to your company with the necessary files and provide support for the inspection.