• Phone: +44 (0)1476 570819
  • Email: bd@drugsafetysolutions.co.uk
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OUTSOURCING

At DSSL, we offer flexible sourcing solutions to support your pharmacovigilance system, or in many cases our clients ask us to provide a full PV service, including the provision of the EU QPPV or signal management in pharmacovigilance. Onto every project we deploy an experienced team of professionals who bring with them a bespoke approach to ensure you get the highest quality, value added service. Our services include:

  • Provision of EU Qualified Person for Pharmacovigilance (EUQPPV) – or National Responsible Person (NRP)
  • Set up and operation of PV System, including System Master File (PSMF)
  • Adverse Event processing
  • Aggregate Report Authoring (PSUR/DSUR/PADER)
  • Literature monitoring
  • Signal detection and evaluation
  • Risk Management and Minimization
  • Registration to EudraVigilance and registration of products in xEVMPD
  • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance