Job Title

About the CompanyAs an Ophthalmologist within the clients R&D Clinicals team, you will work with pre-market and post-market clinical trial activities to ensure safety compliance with protocols, ICH-GCP, and regulatory requirements (e.g. FDA, EU-MDR, ISO etc.), while serving as the primary medical contact for internal and external investigators.About the RoleAs the Ophthalmologist you will be responsible for ensuring safety compliance and serving as the primary medical contact for clinical trial activities.ResponsibilitiesServe as Medical Monitor for pre-market and post-market clinical trial activities to ensure safety compliance with protocols, ICH-GCP, and regulatory requirements (e.g. FDA, EU-MDR, ISO etc.).Review adverse event (AE) submissions for completeness, clarity, and appropriateness of severity and relatedness classification in a timely fashion to ensure compliance with reporting timelines.Serve as the primary medical contact for internal and external investigators and supporting personnel.Report Serious Adverse Events (SAEs) and Unanticipated Serious Adverse Device Effects (USADEs) to Regulatory Affairs (RA) and the relevant notified bodies, as required, and within required timeframes.Perform monthly review of pre-market AEs with RA.Generate monthly KPI reports for distribution to RA and Quality Assurance (QA) functions for pre-market studies.Work with RA and QA to review global complaints, AEs and failure rates.Serve as SME for protocol, investigator brochure, study reports, etc. relative to safety endpoints.Provide safety input into Product Hazard assessments and evaluations.Support R&D QA during audits for inquiries relating to AE and Product Complaint reporting.Participate in or facilitate Data Safety Monitoring Board (DSMB) reviews.Develop and oversee delivery of safety training materials.Collaborate with RA on review and assessment of documents of external origin (DOEO) and relevance to ongoing clinical activities.QualificationsMD ophthalmologist with active license.Required SkillsExperience with safety reporting and/or Health Hazard Evaluations.Understand standardized medical coding, GCP, ISO and regulatory reporting requirements.Ability to manage multiple projects and adjust to changing priorities.Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology.Optometry or ophthalmology background/training.Preferred SkillsIdeally 7-10 years of experience with pharmacovigilance, regulatory affairs or medical monitoring.Experience in contact lens or medical device industry preferred.Pay range and compensation package