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:
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 medical evaluation of Individual Case Safety Reports (ICSRs) alongside the study Medical Director/Clinical Science Specialist for assigned products.
- Contribute to the planned BLA/MAA activities and act as subject matter expert for safety related content.
- In collaboration with internal stakeholders and external vendors, direct the devel-opment, preparation, and compliance of periodic and annual safety reports (e.g., DSUR) & investigator communications as necessary.
- Respond to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
- Lead clinical safety and benefit risk sections of regulatory documents and prepa-ration for meetings with regulatory and public health authorities and advisory com-mittees.
- Lead and contribute to the development of the Risk Management Plan.
- Act as the safety representative on cross-functional development teams including study teams.
- Provide safety related training to company employees as is required.