Drug Safety Physician

AurigaVision AG seeks a Drug Safety Physician for a part-time hybrid role in Switzerland. The position focuses on medical assessment of safety data, including ICSR review, causality evaluation, and aggregate reporting.

The company is looking for a medical professional to oversee the evaluation of drug safety information. This role ensures that adverse events are properly assessed and that safety reports meet regulatory standards.

Responsibilities

• Conduct medical reviews of individual case safety reports (ICSRs).
• Determine the causality, seriousness, and expectedness of adverse events.
• Draft aggregate safety reports, signal assessments, and benefit-risk evaluations.
• Contribute medical expertise to risk management plans and REMS programs.
• Engage in safety governance committees and interact with regulatory authorities.

Requirements

• Hold a medical degree (MD) with a valid medical license.
• Possess 3-5 years of experience in drug safety or clinical development.
• Demonstrate strong medical assessment skills across various therapeutic areas.
• Be familiar with MedDRA, EU GVP modules, and CIOMS reporting.
• Have excellent written and verbal communication skills in English.