Covance

Senior Drug Safety Support Specialist

IN
Job Number
2017-14724
Job Category
Clinical Operations
Position Type
Full-Time

Job Overview

  • 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.

Education/Qualifications

Educated to at least GCSE level or equivalent.

H.S. diploma or equivalent, some college preferred.

Experience

  • 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.
  • Ability to operate standard office equipment.

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