Director Pharmacovigilance & Drug Safety

Job Purpose

The Director Pharmacovigilance & Drug Safety serves as the Pharmacovigilance/Drug Safety Lead for safety surveillance & risk management activities for MoonLake’s clinical development programs.

Key Accountabilities:

• Developing and maintaining an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context (e.g disease under study, safety profile of competitors, mechanism of action).
• Safety lead for safety surveillance activities, and accountable for the ongoing signal detection, evaluation, and periodic review of emerging safety data (e.g AEs, SAEs, Labs), assess for safety trends, and timely presentation of important/urgent safety issues together with risk communication/management strategy to the Drug Safety Committee (DSC), company senior management and external stakeholders (e.g Independent Data Safety Monitoring Boards).
• Provide...