Drug Safety Unit Resource

JOB DESCRIPTION:
Enter applicable information into the global safety database for initial or follow up cases received via paper, fax or email.
Book-in, quality check and initially assess cases from suppliers sending cases to DSS via paper, email or fax.
Accept E2B cases received through the Electronic Submissions Module (ESM) from European Health Authorities on behalf of offices that are not online with the ESM and other submitters as necessary.
Monitor electronic mailboxes and ESM to ensure timely acceptance of Adverse Event (AE) Reports.
Perform data entry into databases, as needed.
Ensure proper coding of events and drugs for cases to ensure correct forwarding to the relevant groups.
Upload AE reports to the Drop in Data Entry II application on behalf of country offices cannot on their own.

SKILLS:

REQUIREMENTS:
BA degree required with 1-3 years of Safety/Pharamacoviliance Data experience.
Scope of work Data entry/case receipt/Book-in/quality check/E2B

REQUIRED SKILLS/BACKGROUND: Electronic Submissions Module, Outlook, Excel.

MOST CRITICAL SKILLS NEEDED: Data entry-ESM