Job Description
Description
As the Global Head of Clinical Safety, you will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab). This involves signal detection, risk management, risk mitigation/management plans, safety analyses in aggregate reports, providing input into publications and data dissemination activities and managing the PV relationship with a key business partner.
This position is also responsible for the medical review of safety-related information in study protocols, study reports, investigator brochures, product labelling (including CCDS), periodic/aggregate reports, risk management plans and responses to specific questions from health authorities.
The Global Head of Clinical Safety will line manage a team of pharmacovigilance (PV) staff in different locations around the world who are focused primarily on clinical deve...