Medical Safety Coordinator/ Ophthalmic Technician

Role: Global medical safety contractor/MDR
Location: Fort Worth, TX
Duration: 12+ months
Global medical safety contractor/MDR (Monday Thursday onsite in Fort Worth, TX, and Fridays WFH)
Optometry/ophthalmology background or at least someone that has worked in the area and understands the eye, for example, an experienced ophthalmic technician; and/or
Experience in managing medical device clinical trials
Job Purpose
Perform Medical Safety activities for assigned Alcon projects or products, primarily (but not limited to) supporting clinical study activities.
Job Functions
Provide input for safety sections for study protocols, study reports, clinical overviews, and regulatory documentation pertaining to EU MDR post-market clinical follow-up activities.
Monitor the safety of assigned products/projects, including adverse events and patient impact from technical complaints (device deficiencies) from studies, literature, and post-market surveillance.
Compile, analyse, and interpret clinical and scientific data from multiple sources; summarize safety trends with supervisory guidance.
Support the preparation and maintenance of post-market surveillance plans, periodic safety updates, product labelling and related documents.
Perform medical review of single cases and/or aggregate data as needed.
Complies with all policies and standards.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Minimum Education/Experience
Bachelor's Degree or Equivalent years of directly related experience in ophthalmic clinical research or safety surveillance.
Preferred Education
Education Level Education Details
Advanced Degree MD or OD is strongly preferred but essential for associates performing medical review. Master of Science or health-related discipline is considered, and the preferred discipline is contingent on the assigned therapeutic area(s).
Minimum Work Experience
5 Years of Relevant Experience
Preferred Work Experience
2 years' Relevant industry experience in product development, such as medical safety, clinical research, or regulatory affairs.
Knowledge, Skills And Abilities
Knowledge of ocular anatomy, common ocular conditions/diseases, and ophthalmic treatment or surgical procedures Medium
Knowledge of regulatory safety requirements for clinical studies and post-market surveillance for assigned therapeutic area(s)
Understanding of product development process and risk assessment principles Medium
Ability to compile, analyse, and interpret large datasets for summary input into safety surveillance strategy Medium
Ability to work independently and as part of a team
Self-motivation and a strong sense of ownership and accountability
Strong communication, interpersonal, and organizational skills
Strong attention to detail and problem solving skills
Proficiency in Microsoft Office required High