Contract Medical Safety Expert (Pharma MD) – AI-Driven Adverse Event Detection

The Contract Medical Safety Expert will provide clinical and regulatory guidance on pharmacovigilance and US FDA AE reporting requirements. Responsibilities include partnering with AI/ML and Clinical Informatics teams to design annotation schemas, define clinically validated criteria for AE identification, and contribute to the refinement of classification taxonomies for adverse events. The role also involves reviewing model outputs, participating in error analysis, defining safe fail protocols, informing data collection strategies, and ensuring compliance with FDA pharmacovigilance standards.