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Manager, Product & Team Support US Clinical Safety DSS Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2373761 |
| Location: New York City, New York |
Date Posted: 7/16/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6513486 |
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Job Description:
Provides updates to the Clinical teams regarding SAE volume, study drug related cases, Investigator site AEM form completion issues and other site related issues that arise Leads issue management between the Clinical Teams and other stakeholders and Communicate any issues or process changes immediately to Clinical and therapeutic team members Attends scheduled meetings deemed necessary for the assigned products Assists with safety reporting working practices and process development Provides feedback to the Senior Management regarding issues that arise with investigator sites or monitoring CROs which may require evaluation of current reporting processes Provide potential contingency plans for ensuring the project timelines for query resolution are met Provide input/feedback to the clinical teams and DSS regarding SAE case processing tasks. Attends teleconferences with DSS sites, USCS SAE Case Processing Manager, Vendor Manager and Clinical team member (if needed) in order to clarify and resolve issues Liaises with the USCS Project lead for SAE Case Processing issues regarding Clinical team issues Acts as an SME regarding clinical safety issues, troubleshooting when necessary regarding issues that arise concerning training questions from Clinical Team members Addresses and documents any inefficiencies that become apparent regarding protocol support, providing resolutions for any issues identified Provides all appropriate study information to USCS Associate Director (point of contact with the Vendor) e.g. Final protocols, Investigator lists, Team Contact lists during study planning phase, continually providing updates through the study Reviews and approves all study tools/documents collaborating with the USCS Associate Director/Vendor manager (Protocol information sheets, etc) that are developed by the vendor Provides updated product and clinical team contact information in order to maintain a current USCS Protocol Support Spreadsheet for all Active and Planned studies.
For more information, please click here to visit us at PharmaceuticalCrossing
For further information, please visit us online at http://www.pharmaceuticalcrossing.com
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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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