GPS Safety Physician
IPSEN
The role will support the Global Patient Safety Therapeutic Area Leaders with scientific analysis, data reviews, signal management and risk assessment activities, evaluation of product quality issues and emerging safety issues, including contribution to safety documents. You will be required to: Provide scientific review and interpretation of safety data for the preparation of aggregate reports such as Development Safety Reports (DSURs), Periodic Safety Update Reports (PSURs), etc; this includes the management and monitoring of vendors used to author such documents Ensure proactive safety and risk management for all assigned products: Through an ‘Integrated Safety Sciences’ collaborative approach, implement proactive safety and risk management strategies, agreed cross-functionally with product team colleagues for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions Ensure that clinical development plans/life-cycle mangement plans adequately address the safety questions and deliver the safety strategy for approval by safety governance Lead the development of the Risk Management Plan for assigned products as applicable Member of the Risk Minimisation Programme Team (leadership of this team may be delegated by the respective GPS TA Leader), and ensure...
Zimbabwe : International
2020-11-24
Contact our recruitment agency in Zimbabwe