✨ The Role in One Sentence

MoonLake is seeking a Director of Pharmacovigilance & Drug Safety to lead safety surveillance and risk management for clinical development programs.

📋 What You'll Likely Do

• 30%: Lead safety surveillance activities, including signal detection and evaluation of emerging safety data.

• 25%: Provide medical evaluation of Individual Case Safety Reports (ICSRs) and contribute to BLA/MAA activities.

• 25%: Direct the development and compliance of periodic safety reports and respond to regulatory safety questions.

🧑‍💻 Profiles Doing This Job

• High Priority: Qualified Physician (GMC or GMC permissible).

• High Priority: Solid experience in clinical safety and pharmacovigilance, specifically in phase III trial activity.

• High Priority: Strong knowledge of international pharmacovigilance requirements.

📈 How This Role Will Look on Your CV

• Led pharmacovigilance and drug safety activities for clinical development programs in a biotech environment.