about 1 month ago
Hamlyn Williams is working with an innovate biopharmaceutical company that is in a major phase of growth due to its exciting pipeline and recent regulatory approvals of its leading drugs.
• Providing scientific expertise during signal detection activities that drive Benefit-Risk assessment reports, support of Company Core Data Sheets and other similar reports.
• Providing scientific review and interpretation of safety data for preparation of aggregate reports such as Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) etc
• Contributing to the preparation and review of pharmacovigilance documentation for internal and external use by providing scientific expertise to the preparation of responses to internal and external questions relating to the safe use of company products.
• To scientifically review the safety components of marketing authorization applications (MAA, BLA and NDA).If you are experienced in signal detection, risk management or benefit-risk assessments, don't hesitate to get in touch!