Senior Safety Lead
Fort Worth Metro Area, TX
Perform device safety activities, including identification and comprehensive assessment of safety signals from all sources (clinical through post-approval lifecycle management).
Perform single case medical review in the safety database or line listings. Medical review will be performed by clinically/medically qualified associates.
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.
- At least 4 years of industry experience in product development, clinical trial methodology, and regulatory requirements (preferred)
- Proven ability to analyze, interpret, and discuss safety information
- Excellent written and verbal communication skills
- Optometrist with extensive knowledge in ophthalmic surgeries may be considered
- MD or OD is preferred but essential for associates performing medical review of single case reports.
- Minimum requirement is Master of Science or health-related discipline