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Eudralex volume 9a

Current vacancies

 

Pharmacovigilance 

The requirement for an accurate and comprehensive pharmacovigilance system that will monitor risk:benefit profiles throughout the clinical trial phase and post-marketing is essential to the protection of patients and public health.

In the past few years new directives and regulations have been implemented to enhance the way in which patient safety monitoring is conducted. Some of these new requirements place significant burden both in terms of resources, expertise and time needed to ensure compliance.

Unicus offers a highly skilled team of pharmacovigilance experts, including pharmaceutical physicians, who collectively possess over 120 years experience.

We provide a full pharmacovigilance (PV) service to a broad range of clients that includes:

  • Processing of AE reports from Clinical Trials or Post Marketing use.
  • Validated safety database (ARISg).
  • Expedited reporting of single cases to Competent Authorities, EMEA, Ethics Committees, Institutional Review    Boards and investigators, as appropriate.
  • Monthly line listings and Annual Safety Reports.
  • Post marketing safety reporting to Competent Authorities and EMEA.
  • Periodic Safety Update Reports.
  • Global weekly literature searches
  • Risk Management Plans
  • Medical safety reviews
  • Training of PV and non-PV staff
  • Preparation for PV audits
  • Unicus can work with you to define solutions to ensure you meet your pharmacovigilance obligations and remain fully compliant!

     

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