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Drug Safety Compliance Manager Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2341031 |
| Location: Ridgefield, Connecticut |
Date Posted: 7/4/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6038787 |
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Job Description:
Excellent communication and negotiation skills are required in order to facilitate discussion on reporting process, participation in working groups and interaction with a variety of departments, other pharmaceutical companies, government agencies and CROs. Experience with computerized safety or clinical data systems (entry and retrieval) as well as other computer based applications (word processors/spreadsheets) is also required. Conduct quality control review(s) of Adverse Event Cases, of all types (non-serious, serious, expedited), report findings; and follow-up on resolution of issues to ensure compliance to Corporate SOPs and FDA regulations. Effectively communicate quality issues and potential solutions to management. Work closely with the Associate Director, Safety Operations to identify, develop, and implement continual process improvements based on QC review findings. On a monthly basis review and monitor regulatory submissions and apply knowledge of applicable FDA/ICH regulations and guidelines to determine if the appropriate reporting of cases has occurred. Maintain spreadsheets of late IND and NDA cases to FDA. Ensure DS department is compliant with current FDA/ICH regulations.
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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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