Phlox PVMed Consultancy has fully qualified experts with decades of experience in global pharmacovigilance. Examples of the services we offer include
- Setting up a pragmatic and compliant pharmacovigilance system for signal identification, validation and documentation that is appropriate to the size of the company and lifecycle of the products
- Creating a complex surveillance strategy such as is needed for advanced therapeutic medicinal products (ATMPs) or vulnerable patient populations
- Rationalising the signal managment system for a large portfolio of mature products
- Mentoring 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 and pooling across studies
- Setting up and appraising 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