Pharmacovigilance
and Drug Safety

With a set of procedures and a qualified Pharmacovigilance staff, we provide the fulfillment of key PV functions, including the QPPV role on behalf of your Organization to follow these tasks:

• PV System management
• Main point of contact for Cas, EMA and Inspection (24/7 availability)
• Oversee the safety profile of your portfolio
• Assessment of the benefit-risk balance
• Review and approval of PASS
• Management of Risk minimisation measures

Our services include drafting, reviewing and providing full support for the management of the Pharmacovigilance System Master File PSMF, ensuring complete adherence to regulatory requirements. Our template is a dynamic document, systematically updated and managed proactively and in interaction with the Client.

Our Risk Management experts may help you drafting, reviewing and submit an RMP classifying important, identified and potential risks. Additionally, we help our Clients in establishing appropriate RMMs to maximise the use of your products and increase the safety of your products.

We take care of all aspects of Eudravigilance registration and maintenance, providing you qualified and trained users to manage all modules embedded within the European database.

We consider pharmacovigilance a cross-cutting element of your organization by implementing a Quality System that clearly describes internal and external communication processes to ensure that safety information is exchanged effectively within the Pharmacovigilance system.

This starts with the drafting of an ad-hoc quality manual

From PSURs to “Signal Detection” or signal search through RMPs and ACOs, our service includes planning, reviewing and submitting aggregate reports. A constant update of the risk/benefit ratio as well as the efficacy and safety of products is ensured by our team of technical and medical experts. Analysis and monitoring activities are performed throughout the drug lifecycle, from the clinical development phase to commercialization.

The service is highly customisable according to requirements. In addition to the systematic global literature review service, we undertake medical analysis of specialised databases and local literature analysis.

With an average of 20,000 ICSRs handled each year, our service ranges from case collection to the evaluation of individual procedural steps, from the rental of the Security Database to the regulatory submission of ICSRs.

Our experience combined with our procedures and resources enables us to deliver these services efficiently and in a highly customisable manner:

• Data entry
• Medical evaluations
• ICSR Submissions
• Quality Control
• ICSR validation
• Safety database

Our safety database is implemented and validated based on the GAMP5 guidelines.

Each customer has its own specific site within the software, managed with a certified process. Our database has Oracle software that ensures adherence to EMA and FDA requirements. All ICSRs are tracked in the database to produce CIOMS, Line listings, reports and summary tabulations, such as Signal Detection, Data Reconciliation and General Reports.

The management of third parties, including business partners, vendors and providers is a key process within the pharmacovigilance system. We take care of your partners and vendors, activating pharmacovigilance and SDEA Safety Data Exchange Agreements and ensuring that pharmacovigilance activities are conducted in compliance with them.

Through timely and appropriate submission of ICSRs, we ensure the highest level of adherence to regulatory requirements and third-party expectations. We achieve these results through our established procedures and dedicated staff.

In collaborazione con il nostro reparto di Ricerca clinica ci assicuriamo che le informazioni di farmacovigilanza degli studi clinici siano tempestivamente e adeguatamente gestite, garantendo la sicurezza dei pazienti durante lo studio.

Siamo in grado di supportare lo Sponsor nella gestione di SAFETY DATA MANAGEMENT PLAN, SAEs, SUSAR e DSUR, cosi come nelle attività di sottomissione e notifica alle parti.

Our QA and Auditor experts support you in the following activities:

• Third-party AUDITS
• Regulatory inspections
• SOP management
• Inspections Follow.up 
• Quality Manuals
• GxP Compliance

GB Pharma, according to its SOP, will be responsible for providing pharmacovigilance training to all client employees (Sales Agents, Regulatory Affairs, Quality Assurance, Qualified person, Scientific Informants, Medical Management, Administration, etc.) and partners (distributors, sales dealers, manufacturers, etc.). These trainings will be carried out on an annual basis according to a training plan prepared by the QPPV.

• Management of local medical information according to local requirement
• Management of request and forwarding to Client