Medical Safety Specialist
Krish SharmaUnited StatesMIDPosted 10d ago
Clinical Trial SafetyAdverse EventsSerious Adverse EventsGCPRegulatory DocumentationMedical NarrativesSafety Data ReconciliationCRO ManagementMedidata RAVE
About the Role
We are seeking a Medical Safety Specialist with hands-on clinical trial safety experience to support medical-device clinical studies. This role involves reviewing and documenting adverse events, supporting clinical safety assessments, and preparing safety reports.
Key Responsibilities
• Review, document, and follow up on Adverse Events (AEs), Serious Adverse Events (SAEs), and device deficiencies
• Support clinical safety assessments, reporting, and safety-data reconciliation
• Prepare safety reports, medical narratives, safety summaries, and regulatory documentation
• Maintain GCP compliance and inspection-ready documentation
Requirements
• Bachelor's degree in Life Sciences, Nursing, Biomedical Sciences, or Healthcare
• 3+ years of safety experience, including clinical trial safety
• Experience with AE/SAE processing, safety documentation, and CRO management
• Knowledge of GCP and US/international regulations for pre-market and post-market clinical studies