Description
As the Integral 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 development PV activities across the development portfolio but which will increasingly involve some post-marketing surveillance and lifecycle management activities as well.
This role will have a significant degree of autonomy and will be highly visible within the organization with broad exposure to senior management. You will have the opportunity to make a meaningful positive impact on the lives of patients and consumers who suffer from a variety of dermatological conditions and to live the Galderma vision which is "Advancing dermatology for every skin story ".
The role reports tothe Global Head of Pharmacovigilance Risk Management
Relocation from within the EU/UK will be supported for the right candidate.
Key Responsibilities
Propose and recommend measures aiming at minimizing risks during clinical development; release and update the Development Risk Management Plans (DRMPs) Partner with internal and external stakeholders to ensure monitoring of safety profile for assigned compounds, signal validation and signal evaluation, and pr

📌 Global Head of Clinical Safety (Barcelona)
🏢 Galderma
📍 Barcelona