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Title : NVA- Sr Safety Lead -747
State : Texas   Date : Oct 4, 2018
Experience Level :  
Position Type : Sr Safety Lead      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location:  Fort Worth, TX


Job Title: Sr Safety Lead


Duration:  6+ months (extendable) contract on W2


Duties:


Serve as a scientific safety lead for assigned ophthalmic products (intraocular lenses and cataract equipment).

Perform single case medical review in the safety database or line listings and prepare safety narratives.

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.

Provide medical/scientific guidance to local affiliates on safety issues.

Contribute to signal detection, monitoring, evaluation, and appropriate management of safety information from all sources (clinical through post-approval lifecycle management).

Contribute to post-market surveillance plans, periodic safety update reports, product labeling, and related documents.

Prepare and present safety issues to internal governance boards.

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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Many Thanks,   

Sree Kanth
Associate Recruitment Manager
NewAge Clinical,
A Division of NewAgeSys, Inc.
231 Clarksville Road, Suite 200,
Princeton Junction, NJ 08550
Tel#: 609-945-1736, Fax: 609-228-4079
Email: sree@newageclinical.com

Website: http://www.newageclinical.com, www.newagesys.com
Inc 5000 Company for 8th Time 

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