
Asst I Pss
4 days ago
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.
- assist with the 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. word processing, proof-reading and editing correspondence/documents, mailings, filing, faxing, photocopying and archiving etc).
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.
Maintain and distribute a weekly schedule for PSS staff.
Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
Build and maintain good PSS relationships across functional units.
Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs)).
Assist the Spec I PSS/Snr Spec PSS in preparation of materials needed for client and/or investigator meetings.
Any other duties as assigned by management.
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