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.
Educated to at least GCSE level or equivalent.
H.S. diploma or equivalent, some college preferred.
2 to 5 years of experience required, safety experience preferred.
Supervisory experience, but not necessarily line management experience.
Office experience or equivalent training.
Ability to set priorities and handle multiple tasks.
Pays attention to detail.
Good team player.
Good written and verbal communication skills.
Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.
Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.