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Clinical Safety Manager

Fort Worth, TX 76134

Posted: 11/01/2022 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 495217 Country: United States Is job remote?: No

Job Description

• Perform Medical Safety activities for assigned projects or products, primarily (but not limited to) supporting clinical study activities.

1. 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.

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
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
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)
Understanding of product development process and risk assessment principles   
Ability to compile, analyze, and interpret large datasets for summary input into safety surveillance strategy
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

Licenses and Certifications (Preferred)
MD  - Physician - State Licensure   Ophthalmologist
OPT - Optometrist

Pay ranges between $70-110/hr  **salary will be commensurate with experience**
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