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 PV&DSS personnel (e.g. word processing, 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).
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.
Maintain and distribute a weekly schedule for PV&DSS staff.
Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
Build and maintain good PV&DSS 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 DSA/Sr. DSA in preparation of materials needed for client and/or investigator meetings.
Any other duties as assigned by management.
Educated to at least GCSE level or equivalent.
H.S. diploma or equivalent, some college preferred.
2 years of office experience.
Attention to detail.
Solid written and verbal communication skills.
Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.
Knowledge of MS office Windows applications beneficial.
Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.