How can JensonR+ help you?

The aim of pharmacovigilance is the safer and more effective use of medicines for everyone. It involves all activities that relate to noticing, assessing, understanding, managing and preventing adverse effects of medicines for individuals and populations.

From the moment a marketing authorisation is applied for and throughout the life of a medicinal product, safety monitoring is an obligation.

JensonR+ have a dedicated Pharmacovigilance team headed by our own in house Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV.  The Jenson team will ensure you maintain compliance and that patient safety is effectively monitored for your products.

Jenson’s Pharmacovigilance team implement a fully validated safety database for managing your products safety profiles.  We are able to design bespoke databases catering for the scale of your operations.  For smaller clients with single clinical trials to global big pharma companies with a whole portfolio of products – The pharmacovigilance team can provide expert support for the management of your products.

We can provide a full pharmacovigilance service designed to meet the complex and changing needs of the global environment, for both medicinal products and medical devices.

We provide the following services:

  • Post authorisation pharmacovigilance

  • Medical device vigilance

  • Pharmacovigilance auditing and training

  • Solicited data monitoring

  • Aggregate report writing

  • Risk management plans

Post marketing pharmacovigilance support

We offer a flexible and bespoke pharmacoviglance service. Whether you are a small generics company or hold multinational licences with large case volumes.

Our services include:

  • QPPV services

  • Pharmacovigilance system master file preparation and management

  • 24-hour Pharmacovigilance cover

  • Medical Information service

  • Electronic management of Adverse Event reports on in-house bespoke database

  • Electronic expedited reporting (EudraVigilance)

  • Global Literature Search and Reviews

  • Signal detection

  • Provision of Periodic Safety Reports (PSURs)

  • EudraVigilance set up and oversight, liaison with Competent Authorities

  • Auditing of pharmacovigilance systems

  • Risk Management Plan (RMP) writing

  • Pharmacovigilance training

Medical Device vigilance

JensonR+ can take care of your vigilance system regarding devices.

We can provide support to manufacturers of devices to ensure a fully compliant post marketing vigilance system, including:

  • Contact point for customer feedback and the reporting of incidents

  • Management and databasing of incidents reports

  • Reporting of incidents to the relevant competent authorities

  • Collaboration and information collection for incident investigations

  • Management of Field Safety Notices and Field Safety Corrective Actions

  • Creation of Post Market Surveillance plans and Post Market Clinical Follow-up plans

  • Trend reporting and PSURs

  • Scientific Service for devices

  • 24hr contact point for notified bodies and competent authorities

  • Provision of device vigilance training

Pharmacovigilance auditing and training

As part of our service provision JensonR+ operate a continuous improvement programme to ensure we are providing the best service, within which we conduct self-assessment and external quality audit. JensonR+ pharmacovigilance undertake external audit on behalf of clients, providing a full assessment of systems in use and sharing advice on areas for improvement.

All staff employed within a medicinal product organisation are required to receive training to recognise potential safety information and know what to do with it. JensonR+ are able to provide this training to make sure your organisation is compliant in this respect.

Clinical trial data monitoring

We can offer scalable services for small Phase 1 studies through to larger post authorisation patient studies.

Our services include:

  • Collection and follow-up of Serious Adverse Events (SAEs) from clinical trials

  • Electronic management of SAEs including expedited reporting to Competent Authorities

  • Expedited reporting to Ethics Committees and investigator sites

  • Six monthly and quarterly reporting to Competent Authorities and Ethics Committees

  • Responsible Person for Eudravigilance oversight

  • Reconciliation with clinical database

  • Compliance review and oversight

  • Eudravigilance set up and management

Named patient and compassionate use programmes

We provide services to support monitoring of specific programmes including:

  • Collection and follow-up of Adverse Events (AEs) from named-patient and compassionate use programs

  • Weekly literature searches of Pub Med

  • Electronic management and expedite reporting to Health Authorities

  • Eudravigilance set-up and management

  • EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight

  • Compliance oversight

  • 24-hour cover

  • Eudravigilance set-up and management

Talk directly to one of our experienced team

David Lough
Deputy QPPV & Senior PV Officer
Erika Barbarosie
EU Qualified Person For Pharmacovigilance
Jenson R+ Ireland