Product Safety and Benefit–Risk Management
We provide strategic medical leadership for the safety and benefit–risk management of investigational and marketed products. Services include:
- Development and implementation of product safety and risk management strategies throughout clinical development and post-authorisation use
- Medical oversight of evolving product safety profiles
- Identification, evaluation and characterisation of emerging and established risks
- Integration of safety evidence from clinical trials, spontaneous reports, scientific literature, epidemiological studies and non-clinical findings
- Benefit–risk assessment of new and evolving safety information
- Development of evidence-based safety positions and recommendations
- Escalation and presentation of significant safety issues to scientific and governance committees
- Translation of safety conclusions into appropriate clinical, regulatory and risk-management actions
- Development of risk assessment and risk minimisation strategies and activities.
- Support for product labelling, safety communications and regulatory submissions
We work collaboratively with the company’s cross-functional teams including Safety and Pharmacovigilance Scientists, Clinical Development, Regulatory Affairs, Medical Affairs, Epidemiology, Biostatistics, and Non-clinical Development stakeholders.