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COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.
We are currently recruiting Drug Safety Support Specialist to join our team in Sofia, Bulgaria.
This is a 6-month fixed term contract position.
Duties and Responsibilities:
- 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 personel, if required, within study specified time lines.
- 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.