Assistant Ii, Pss
5 months ago
Data entry of safety data onto adverse event tracking systems
- Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable)
- Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)
- Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed
- Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Labcorp project personnel, as required within the agreed timelines
- Maintenance of adverse event tracking systems
Assist with peer/quality review of processed reports and support with trends and actions as needed
Assist in the reconciliation of databases, as applicable
Assist in the maintenance of files regarding adverse event reporting requirements in all countries
Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate
Prepare and support coordination of safety study files for archiving at completion of projects
Arrange and schedule internal and/or external meetings/teleconferences
Train and mentor the PSS Assistants or peers in their day-to-day activities
Build and maintain good PSS relationships across functional units
Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans
Assume responsibility for quality of data processed
Provide administrative support to PSS personnel
Any other duties as assigned by the management.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our
Privacy Statement
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