Phlox PVMed Consultancy has fully qualified experts with decades of experience in global pharmacovigilance.
SERVICES WE OFFER
- Review of historical and newly identified signals and creation of a signal managment strategy for specific products
- Set up a pragmatic and compliant pharmacovigilance system for signal identification, validation, review and documentation of final decisions that is appropriate to the size of the company and lifecycle of the products
- Rationalise the signal managment system for a large portfolio of mature products
- Mentor newly appointed product safety leads needing support and training for advanced signal montoring activities
- Routine montoring of clinical development including SAS creation, working with statisticians, programmers and clinical operations colleagues to create the most efficient outputs including pooling across studies
- Set up and appraise post marketing signal management for the most appropiate approach taking into account the maturity, risk managment plan safety concerns, routine and additional pharmacovigilance and risk mitigation activities for the product