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Pharmacovigilance

Northumbria Pharma are dedicated to providing a comprehensive Pharmacovigilance (PV) service. Our experienced team supports both our own in-house products and we also offer this service to a variety of aligned companies. 

Our services are tailorable to suit individual company needs: to request more information on our pharmacovigilance offering please contact: Pharmacovigilance

PV System Maintenance

  • Provision of QPPVs covering UK, EU and local national requirements

 

  • Generation and maintenance of PSMFs

 

  • Regulatory system registration and maintenance

 

  • Creation and fulfilment of Safety Data Exchange Agreements

Risk Management

  • Preparation and maintenance of Risk management plans

 

  • Implementation of additional PV and risk minimisation measures

 

  • Aggregate report preparation and submission

 

  • Signal detection and ongoing safety monitoring

 

  • Global and local literature screening

 

ICSR Management

  • End to end case processing including receipt, entry, quality review, medical review, follow-up and submission

 

  • Regulatory compliant hosted database

 

  • Automated ICSR import and submission via E2B gateway

 

  • Medical coding (MedDRA, WHO DD)

Regulatory expertise

  • Robust regulatory intelligence process to ensure ongoing compliance with PV regulations

 

  • PV awareness training to PV and non-PV staff

     

  • Regular interaction with regulatory authorities

 

  • Participation in PV audits and inspections, and subsequent CAPA management activities

     

     

PV

Medical Information
For any product related enquiries from healthcare professionals or patients, please do not hesitate to get in touch:

Email: ukmedinfo@northumbriapharma.com

Tel: 01740 618611

Adverse Events
Adverse events should be reported via Yellow Card. You can find reporting forms and information at:

Yellow Card

Alternatively, adverse events can be reported to Northumbria Pharma, Tel. 01740 618611