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
