Drug Safety Data Management Specialist

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 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 Therapeutic Area Teams and Licensing Group.
- Upload AE reports to the Drop in Data Entry II application on behalf of country offices cannot on their own.

SKILLS:

QUALIFICATIONS:

- MS Excel
- MS Outlook
- MS Word
- MUST HAVE ESM experience
- BA degree required with 1-3 years of Safety/Pharamacoviliance
- Data experience.