& QPPV Services
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. A Market Authorisation Holder has a legal obligation to monitor the safety of their products.
We can set up and manage the required quality systems to fulfil Marketing Authorisation Holder’s Pharmacovigilance obligations. Alternatively, we can setup the system and train the Clients personnel on its operation.
We have our own in-house Qualified Persons for Pharmacovigilance (QPPVs) and deputy QPPVs situated both in the EU and the UK. We can ensure that patient safety is effectively monitored for your products and you meet all of your compliance obligations.
When we are managing the ‘PV system’ we conduct weekly literature searching to identify potential adverse events related to Marketing Authorisation Holder’s products. We collate, assess, follow-up and report spontaneous adverse reactions received by the Marketing Authorisation Holder. Electronic reporting is done via the MHRA ICSR Submissions Portal or EVWeb (licence dependant).
In support of the PV function we can undertake the following:
EU and UK QPPV – appropriate Qualified Person and Deputy Qualified Person for Pharmacovigilance (QPPV/Deputy) including 24-hour cover
Provision of Medically Qualified Person and 24 hour medical information services
Handling and reporting of Individual Safety Case Reports
Monitoring of the scientific literature, including MLM (where applicable)
Review of ASPRs/PVORs
Preparation, review and maintenance of Pharmacovigilance System Master File
Preparation and maintenance of Technical Agreements and Safety Data Exchange Agreements
Preparation and submission of Periodic Safety Update Reports
Signal detection and Product Safety Reports
Maintenance and updating of product information including SmPC, leaflet and labelling
Production of Risk Management Plans and Risk Minimisation Measures documentation and their implementation
Auditing existing Pharmacovigilance systems and assistance during PV Inspections
UK National contact for Pharmacovigilance
Liaison with the relevant Competent Authorities
Our services and processes are scalable. So, if you have one product or many products with large case numbers, we can provide a full pharmacovigilance service, that is flexible and practical to meet your obligations as Marketing Authorisation Holder.
Let’s Start Something new
If you would like to find out more about any of our services please fill out the form below. We would love to here from you.