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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2350752 |
| Location: Nutley, New Jersey |
Date Posted: 7/8/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6252089 |
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Job Description:
The Position:Medical Evaluation Group is a team of physicians and scientists dedicated to safety signal detection and safety risk management ensuring the safe use of Roche products and thereby contributing to Roche Products business success throughout the life cycle. Proactively identify potential safety signals arising from cliical trials of drugs in development and from marketed products globally Critically evaluate potential safety signals and where necessary develop strategies to enable further assessment of safety signals Develop risk management strategies for significant identified safety risks Provide drug safety and strategic inputs into Roche clinical teams and into Life Cycle Teams Represent Roche as Drug Safety representative at meetings with regulatory authorities and third parties such as licensing or co-development partners, consultants Medical input in periodic reporting documents (PSURs; Annual Safety Reports; etc.) Core Dat a Sheets, Investigators Brochures, Clinical Study Reports, Clinical Summaries and Clinical Overviews (benefit-risk evaluation) Medical evaluation of single case reports Author ASIME, issue workups, query responses (Health authorities, internal requests, health care providers).
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: PharmaceuticalCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.pharmaceuticalcrossing.com
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