Pharmacovigilance Consultancy Services

Pharmacovigilance Consultancy Support

QVigilance has a team of scientific and medical experts with broad experience in all areas of pharmacovigilance. As a result, we can provide guidance and support (including drafting and/or review) in the development/update of Standard Operating Procedures (SOPs)/working practices supporting Pharmacovigilance activities where these are undertaken within your organisation, as:

  • All employee PV training

  • Safety data exchange agreement authoring and maintenance

  • Global safety committee activities

  • Signal management and Risk 
    minimisation activities

  • Development/Maintenance of company core datasheet maintenance (CCDS) and labelling committee governance

  • Safety variations and Urgent safety restrictions

  • Handling safety information from product quality complaints and medical enquiries; including safety information from solicited activities (e.g. registries, market research, patient support programs, company' sponsored social media activities)

In addition, our team can support with:

On-site or remote development and provision of all employee PV training materials

  • Safety data exchange agreements authoring

  • Adverse event and pregnancy forms development

  • Development of educational materials for risk minimisation and creation of targeted questionnaires for specific patient groups, AEs or other safety concerns

  • Benefit-risk communications with competent authorities
  • Review/input into clinical trial protocols, investigator brochures and clinical study reports
  • On-site or remote regulatory inspection support before, during and after the inspection

  • Conducting on-site or remote audits of internal global and affiliate PV departments; as well as audits of contractual partners/providers

  • Provision of consultancy support on safety database, including due diligence, set-up, validation and data migration activities

Speak with our Pharmacovigilance Consultancy team!

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