· 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).
· Any other duties as assigned by management.
· Educated to at least GCSE level or equivalent. H.S. diploma or equivalent, some college preferred.
· 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.
· Ability to operate standard office equipment.
· Japanese language position require excellent reading and writing skills with Japanese N1.