Medical Reviewer Manager

RESPONSIBILITIES

• Triage of adverse event reports in Argus Database
• Medical review of adverse event reports in Argus Database
• Causality assessment of adverse event reports in Argus Database
• Signal management activities
• Medical review of aggregate reports
• SmPC and PIL evaluation, comparison, and updates as required

DESIRED SKILLS

• Expert knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.)
• Experience with ICSR review and assessment
• Strong interpersonal skills and the ability to be flexible in varying environments
• Good attention to detail and decision-making skills.