PHARMACOVIGILANCE

Pharmacovigilance Outsourcing

 

Pharmacovigilance outsourcing is the mainstay solution for small to medium size businesses.

 

A pharmacovigilance outsourcing company should enable its clients to interact with one service provider for all the Pharmacovigilance (PV) and regulatory requirements, which translates into a cost and time effective strategy.

Pharmacovigilance outsourcing to PrimeVigilance is not geographically restricted only to EEA countries. On the contrary, we have been successfully handling clients from all over the world. In brief, over 70 of our PV clients are located in Europe, US, Australia, the Middle East and Asia and as a result of their products distribution, marketing authorisation status and study sites we are responsible for clinical and/or post-marketing PV services for approximately 500 medicinal products distributed across more than 100 countries globally.

For over a decade now, PrimeVigilance stands out among pharmacovigilance service providers worldwide. Pharmacovigilance consulting services offered by PrimeVigilance consist of but are not limited to consulting services – e.g. benefit-risk analysis, Safety data exchange agreement (SDEA) development, and development of standard operating procedures (SOPs), European Economic Area (EEA) Qualified Persons for Pharmacovigilance (QPPV), local QPPVs, Auditing services, aggregate report writing, clinical trial and post-marketing case processing, safety database, data migration, regulatory reporting, development of risk management plans (RMPs), Signalling (detection, evaluation and validation), literature search, development of the pharmacovigilance system master file (PSMF), publishing and submission.

 

Provision of EEA Qualified Person for Pharmacovigilance (EEA QPPV)

PrimeVigilance offers experienced EU Qualified Person for Pharmacovigilance (QPPV) and Deputy QPPVs with extensive knowledge and experience of the industry.

Safety Data Exchange Agreements (SDEA)

Safety Data Exchange Agreements are legal written contracts ensuring that all safety data regarding a licensed product makes its way quickly and reliably back to the marketing authorisation holder so that they may fulfil their legal obligations to aggregate safety data and to submit safety reports in a timely manner.

Safety Database Solutions

PrimeVigilance is equipped with fully supported safety database solutions for a compliant and effective pharmacovigilance system.

Pharmacovigilance System Master File (PSMF)

EU Directive 2010/84/EU (amending 2001/83/EC) requires each application for Marketing Authorisation (MA) for the EU to have a Pharmacovigilance System Master File (PSMF) in place including the named Qualified Person responsible for Pharmacovigilance within the EEA.

Provision of a National Person Responsible for Pharmacovigilance (NPRP)

PrimeVigilance offers an extensive network of “Local QPPVs” or more accurately known as National Persons Responsible for Pharmacovigilance (NPRP) in the European Economic Area (EEA) countries where the provision of an NPRP is required by national law at the time a market authorization is submitted or when a product receives its marketing authorization.

 

Outsourcing Pharmacovigilance Activities

Outsourcing pharmacovigilance activities to PrimeVigilance guarantees multiple benefits:

  • Expertise and knowledge – PrimeVigilance has a number of ex-regulators as well as PV and Medical Information (MI) professionals within its leadership team
  • Project coordination – PV and MI project leads will communicate on a regular basis. Where appropriate, client teleconferences and monthly reports can be harmonised, if required
  • Processes and monthly reports of the highest quality
  • Robust key performance indicators (KPIs) and exceptional compliance metrics shared with the client
  • Training – Shared PV and MI team product training can be held
  • Issue escalation process is shared
  • Reconciliation can be performed in-house

 

PrimeVigilance is currently providing support to clients whose products cover more than 20 therapeutic areas, among which infectious diseases, oncology, cardiovascular diseases. Pharmacovigilance outsourcing from MAHs of products with orphan drug designation can be a challenge, as these products have specific requirements. PrimeVigilance is ready to face this challenge and overcome any obstacle, as it holds in its armoury a PV team including PV Physicians experienced in handling such safety information and who understand these regulatory expectations.

What a pharmacovigilance outsourcing company should guarantee to its clients besides effectiveness, is compliance, conformity, continuity and reliability. PrimeVigilance’s reputation is underpinned by adherence to the highest quality standards, with a robust quality management system and corrective action and preventative action (CAPA) management process. Always in line with regulatory documents, such as GVP Modules, and with a fully defined disaster recovery and business continuity plan in place, PrimeVigilance’s clients can only rest assured that they have chosen the best pharmacovigilance service provider.

For PrimeVigilance, pharmacovigilance outsourcing is synonymous to assignment of an exceptional project team. As this is paramount to the successful delivery of any project., we will provide experienced and capable Project Managers (PMs) with extensive experience, excellent communication skills and robust management/organisational skills. They will set-up, manage and oversee all aspects of the services provided by PrimeVigilance, and act as your key point of contact. A team of experienced and trained PV employees will be performing case processing, reporting, reconciliation and assist with aggregate report production and other PV activities as required. This team would be supported by our literature, submissions, regulatory, and medical writing teams, each containing subject matter experts in their functional area to perform and ensure compliance with all contracted activities. Each single case and aggregate report will always undergo medical review by a PV Physician, also responsible for performing signal detection and other benefit-risk evaluation activities. All PrimeVigilance employees are fully trained and formally certified prior to performing any of their designated duties.

A pharmacovigilance service provider should offer flexibility, another strong characteristic of PrimeVigilance. We will always try and understand the dynamics of each business and offer the level of management and support tailored to the company’s needs. Regarding case processing in particular, we have the ability to scale up our resources and successfully deal with unexpected fluctuations of case volumes.

Our vision is to be listed among the top pharmacovigilance outsourcing companies. We are constantly working hard towards this direction. Unarguably, we have the knowledge and we have the expertise. Hence, PrimeVigilance is the best solution when considering outsourcing pharmacovigilance activities.