Pharmacovigilance
& drug safety

Why us

A comprehensive and highly-customizable package of Pharmacovigilance services to ensure the safety of your products. Our quality system and pharmacovigilance team allow us to propose a cost-saving outsourcing model.

Our Pharmacovigilance team provides support to ensure the patient safety at every stage of the product life-cycle.

Our team is made up of physicians and pharmaceutical qualified staff providing our Clients with  flexible approaches and solutions to manage their Pharmacovigilance needs.

QPPV & PV Management System

We are the PV Department of our Clients. With a set of procedures and a qualified Pharmacovigilance staff, we provide our Clients with a comprehensive package of services, including the QPPV role, to manage the PV System on their behalf.

Risk Management

Through the synergy of a multidisciplinary team and combining pharmacovigilance, regulatory and clinical services, we support our Clients to promote safe use of medicines and safeguard health of patients by establishing an effective Risk Management System. Our experts can help you in identifying risks related to your products and define the most appropriate RMMs.

Eudravigilance Management

Our qualified PV staff allow us to set-up and maintain an Eudravigilance profile on our Client behalf. We take care to upload and maintain data in the Article 57 database and ensure the ICSR Data Entry is done accurately.

PV Quality System

We consider Pharmacovigilance as a transversal matter of your Organization by implementing a Quality System that clearly describes intra- and inter- communications, so that safety information are efficiently exchanged within the PV System. This starts from designing an ad-hoc and ISO-like Quality Manual.

Aggregate reports

From PSURs to Signal detections, passing through RMPs, our service include planning, drafting, reviewing and submission of aggregate reports. An ongoing overview of the benefit / risk balance as well as of the efficacy and safety of products is assured by a pool of skilled technicians and medical experts.

Literature screening

We offer a systematic worldwide literature screening service as part of your day-to-day drug safety operations. It is highly customable to Client’s needs. The high number of active substances currently monitored by us allow us to establish and maintain a cost saving approach.

Case management

With an average 10.000 ICSRs managed on a yearly basis, our service ranges from case collection to the single step of case processing, passing through the renting of the Safety Database to Regulatory submission of ICSRs. Our experience, together with our procedures and resources, allow us to deliver these services efficiently and in a highly customable way.

Third party management

Third party management is a critical process to make a PV System work efficiently. We take care of your partners and vendors by putting in place PV Agreements and SDEA management and ensure PV activities are conducted in compliance with them.

Safety reporting

Through a high performance of timely ICSR submission and exchange we ensure our Clients the highest level of compliance with regards to third party and regulatory expectations. We do it with a set of procedures, agreements and a skilled staff.

Safety on clinical trials

Through our Clinical Department and Clinical Trial Safety Officers we ensure pharmacovigilance information of clinical trials is timely and properly managed, guaranteeing the safety of patients on clinical trials. We can support Sponsor on managing SDEA, SAEs, SUSAR and DSUR, as well as regulatory submission / notification to stakeholders.

We are the PV Department of our Clients. With a set of procedures and a qualified Pharmacovigilance staff, we provide our Clients with a comprehensive package of services, including the QPPV role, to manage the PV System on their behalf.

Through the synergy of a multidisciplinary team and combining pharmacovigilance, regulatory and clinical services, we support our Clients to promote safe use of medicines and safeguard health of patients by establishing an effective Risk Management System. Our experts can help you in identifying risks related to your products and define the most appropriate RMMs.

Our qualified PV staff allow us to set-up and maintain an Eudravigilance profile on our Client behalf. We take care to upload and maintain data in the Article 57 database and ensure the ICSR Data Entry is done accurately.

We consider Pharmacovigilance as a transversal matter of your Organization by implementing a Quality System that clearly describes intra- and inter- communications, so that safety information are efficiently exchanged within the PV System. This starts from designing an ad-hoc and ISO-like Quality Manual.

From PSURs to Signal detections, passing through RMPs, our service include planning, drafting, reviewing and submission of aggregate reports. An ongoing overview of the benefit / risk balance as well as of the efficacy and safety of products is assured by a pool of skilled technicians and medical experts.

We offer a systematic worldwide literature screening service as part of your day-to-day drug safety operations. It is highly customable to Client’s needs. The high number of active substances currently monitored by us allow us to establish and maintain a cost saving approach.

With an average 10.000 ICSRs managed on a yearly basis, our service ranges from case collection to the single step of case processing, passing through the renting of the Safety Database to Regulatory submission of ICSRs. Our experience, together with our procedures and resources, allow us to deliver these services efficiently and in a highly customable way.

Third party management is a critical process to make a PV System work efficiently. We take care of your partners and vendors by putting in place PV Agreements and SDEA management and ensure PV activities are conducted in compliance with them.

Through a high performance of timely ICSR submission and exchange we ensure our Clients the highest level of compliance with regards to third party and regulatory expectations. We do it with a set of procedures, agreements and a skilled staff.

Through our Clinical Department and Clinical Trial Safety Officers we ensure pharmacovigilance information of clinical trials is timely and properly managed, guaranteeing the safety of patients on clinical trials. We can support Sponsor on managing SDEA, SAEs, SUSAR and DSUR, as well as regulatory submission / notification to stakeholders.

More in detail

Brochure

Pharmacovigilance services

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How we manage your PV System

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International activities

Our PV Network

Since 2006, GB Pharma is a leader provider of global and local pharmacovigilance services. In addition to our membership with REGULANET®, we can offer tailored local Pharmacovigilance services through a network of local providers highly skilled and experienced on Pharmacovigilance topics. Our trusted partners are mid-size Companies that we have been selected and qualified over the years. 

Through this network we ensure our Clients with:

  • High compliance with local pharmacovigilance requirements;
  • Timely and efficient exchange of safety information;
  • High quality of translation activities;
  • A comprehensive list of non-indexed local scientific journals;
  • Qualified staff to act as local contact or responsible person for Pharmacovigilance;
  • A global and tailored PV System.

To date our global coverage reaches the following Countries: European Union, United Kingdom, US, Canada, LATAM, African Countries, China, Russia and Japan.

GB Pharma Services & Consulting Srl Codice fiscale/P.IVA 01900980184
GB Pharma Srl Codice fiscale/P.IVA 02183430186