About the job
- 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 PV&DSS 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 Drug Safety Associate (DSA)/Senior Drug Safety Associate (Sr. DSA).
- 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 PV&DSS hotline mailbox regularly for reported SAEs and forward messages to the designated DSA/Sr. DSA.
- 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 PV&DSS 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 PV&DSS relationships across functional units.
- Any other duties as assigned by management.
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