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Job Description
Global Medical Safety Contractor Fort Worth, TX 12 MonthsJOB PURPOSE • Perform Medical Safety activities for assigned projects or products, primarily (but not limited to) supporting clinical study activities. JOB FUNCTIONS1. 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. 2. 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. 3. Compile, analyze, and interpret clinical and scientific data from multiple sources; summarize safety trends with supervisory guidance. 4. Support the preparation and maintenance of post-market surveillance plans, periodic safety updates, product labelling and related documents. 5. Perform medical review of single cases and/or aggregate data as needed. 6. 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 ExperiencePreferred Work Experience Experience Experience Details 2 years Relevant industry experience in product development, such as medical safety, clinical research, or regulatory affairs.Knowledge, Skills and Abilities KSAs Proficiency 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) Medium Understanding of product development process and risk assessment principles Medium Ability to compile, analyze, and interpret large datasets for summary input into safety surveillance strategy Medium Ability to work independently and as part of a team High Self-motivation and a strong sense of ownership and accountability High Strong communication, interpersonal, and organizational skills High Strong attention to detail and problem solving skills High Proficiency in Microsoft Office required HighLicenses and Certifications Licenses/Certifications Licenses/Certification Details Time Frame Required/ Preferred MD - Physician - State Licensure Ophthalmologist Upon Hire Preferred OPT - Optometrist Optometrist Upon Hire PreferredLanguage Skills Language • The ability to fluently read, write, understand and communicate in English #LI-FRESH