Job Title

Global Head of Clinical Safety

Location

Barcelona, Spain (hybrid)

Overview

As the Global Head of Clinical Safety, you will provide medical safety expertise for the benefit/risk assessment of products in clinical development, focusing on our key biologic (Nemolizumab). Responsibilities include signal detection, risk management, safety analyses, clinical study safety reviews, and managing the PV relationship with our key partner.

Key Responsibilities

• Propose and recommend measures to minimize risks during clinical development; release and update Development Risk Management Plans (DRMPs).
• Partner with stakeholders to monitor safety profiles, validate signals, evaluate risks, and propose risk minimization measures.
• Own aggregate safety reports (DSUR, PSUR, PBRER) and risk management plans (RMP).
• Provide input into safety modules for dossier submission and respond to safety‑related quest...