MD- Ophthalmologist - Safety
Fort Worth Metro Area, TX
- Medical Device- Safety Lead
Education: Ophthalmologist, Optometrist with extensive knowledge in ophthalmic surgeries may be considered
MD Ophthalmology, healthcare field at least 4 years of industry experience in product development, clinical trial methodology, and regulatory requirements
Major Activities Perform single case medical review in the safety database or line listings
Provide guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports.
Monitor the clinical safety of assigned products/projects, including literature review, adverse events, patient impact from technical complaints
Provide safety input into clinical and regulatory deliverables, including Investigator s Brochures, study protocols, reports, and clinical submission documents Identify safety signals based on the review of solicited or unsolicited single cases.
Perform signal triage activities, evaluation, and presentations
Author the safety profiling and risk management documents Lead cross-functional projects and support the Safety Management Team.