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Sr. Safety Lead

Fort Worth Metro Area, TX

Posted: 09/24/2018 Job Type: Scientific Job Number: JN -092018-22632
Description:
Duties:
1. Serve as a scientific safety lead for assigned ophthalmic products (intraocular lenses and cataract equipment).
2. Perform single case medical review in the safety database or line listings and prepare safety narratives.
3. Provide guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports.
4. Monitor the clinical safety of assigned products/projects, including literature review, adverse events, patient impact from technical complaints.
5. Provide safety input into clinical and regulatory deliverables, including Investigator s Brochures, study protocols, reports, and clinical submission documents.
6. Provide medical/scientific guidance to local affiliates on safety issues.
7. Contribute to signal detection, monitoring, evaluation, and appropriate management of safety information from all sources (clinical through post-approval lifecycle management).
8. Contribute to post-market surveillance plans, periodic safety update reports, product labeling, and related documents.
9. Prepare and present safety issues to internal governance boards.
10. Lead cross-functional projects and support the Safety Management Team.

Skills: At least 4 years of industry experience in product development, clinical trial methodology, and regulatory requirements (preferred)
Prior experience in cataract surgery
Proven ability to analyze, interpret, and discuss safety information
Excellent written and verbal communication skills

Education: Ophthalmologist
Optometrist with extensive knowledge in ophthalmic surgeries may be considered
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