Medical Monitor / Medical Vigilance Officer / Medical Safety Officer
Core
Licensed UK ophthalmologist providing expert assessment of adverse events, regulatory compliance for vigilance obligations, and clinical insight into safety signals for a contact lens portfolio.
Role type
Senior Medical Monitor / Medical Vigilance Officer
Builds
Clinical safety evidence and regulatory compliance for pre-market and post-market activities
Domain
Medical devices (soft contact lenses) / Clinical Safety / Regulatory Vigilance
Deliverable
client delivery
Required skills
Medical device vigilance, safety reporting, Health Hazard Evaluations, standardized medical coding, GCP, ISO, regulatory reporting requirements
Preferred skills
Managing multiple projects, adjusting to changing priorities
Technologies
None stated
Responsibilities
Serve as Medical Monitor for pre-market and post-market clinical trial activities; Review adverse event submissions for completeness and classification; Report Serious Adverse Events and USADEs to Regulatory Affairs; Perform monthly review of pre-market AEs; Generate monthly KPI reports for RA and QA; Contribute to benefit–risk assessments and documentation for product investigations; Support clinical assessments for risk management files; Work with RA and QA to review global complaints and failure rates; Serve as SME for protocol and study reports relative to safety endpoints; Provide safety input into Product Hazard assessments; Support R&D QA during audits; Participate in or facilitate Data Safety Monitoring Board reviews; Develop and oversee delivery of safety training materials; Collaborate with RA on review of external documents
Seniority
Senior, hands-on IC