Pharmacovigilance Strategy

  • Consulting with regard to the design and structure of PV systems as companies move into peri- and post marketing phase, or need to expand their PV capabilities
  • When and how to use a Drug Safety Monitoring Board (DSMB) or Safety Evaluation Committee (SEC) pre-, peri- and post-marketing
  • Safety due diligence for company assessments of in-/out-licensing opportunities
  • QPPV consulting

Pharmacovigilance Execution

  • Provision of a QPPV/Deputy QPPV
  • Consulting and project management of set up, management and coordination of reporting of Drug Safety Monitoring Boards and Safety Evaluation Committees
  • Medical Monitoring Phase I-IV
  • Consulting and project management of creation, development and maintenance of PV systems
  • Risk Management Plans and Risk Assessments
  • PSUR writing and Medical review
  • Safety Signal Assessments
  • Support for PV regulatory submissions and representation at Health Authority meetings

Glass Molecule

Technical Services