Requirement SourcePoint | By Innovative

 

  


Requirement Number: 5606

Recruiter Alex Rabinsky
Requirement Type Contract
Requirement Category Clinical R&D - Safety Reviewer
Location Abbott Park IL
Start Date 08/13/2007
End Date 12/31/2007
Number of Openings 1
Max Pay Rate or Salary $27.42
Job Description REQUIRES 0-3 YEARS EXPERIENCE Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. BS Preferred. Responsible for timely review and filing of global ADD Medical Complaints in compliance with FDA regulations (21CFR803 and 21CFR820), IVD Directive, Health Canada and other regulated countries. Review medical complaints, translate clinical information into clear and concise documents, document filing decisions and submit report to regulatory agencies for Adverse Event reporting. Effective communciation skills with personnel worldwide. Highly organized and detailed oriented.
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