- Assist in the processing of expedited safety reports (ESRs). This includes, but is not limited to:
- maintenance of adverse event tracking systems
- set-up and maintenance of project files, core process files and central safety files
- reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines.
- Provide administrative support to PSS personnel (e.g. proof-reading and editing correspondence/documents, mailings, filing, faxing, photocopying and archiving etc).
- Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Spec I PSS/Snr Spec PSS.
- Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs)).
- Where applicable, check the PSS hotline mailbox regularly for reported SAEs and forward messages to the designated Spec I PSS/Snr Spec PSS.
- Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
- Coordinate shipments of safety documents.
- Prepare and coordinate safety study files for archiving at completion of projects.
- Arrange and schedule internal and external meetings/teleconferences.
- Train and mentor the PSS Support Specialists in their day-to-day activities.
- Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
- Build and maintain good PSS relationships across functional units.
- Any other duties as assigned by 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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