Asst I Pss

4 days ago

Bengaluru, India Labcorp Full time

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.
- 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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