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Drug Safety Data Management Specialist
Eingestellt von Synectics
Projektbeschreibung
JOB DESCRIPTION:
- 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 companies that are not online, 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:
EXPERIENCE:
- BA degree required
- 1-3 years of Safety/Pharamacoviliance Data experience
- Electronic Submissions Module
- MS Excel, MS Outlook, MS Word
- 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 companies that are not online, 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:
EXPERIENCE:
- BA degree required
- 1-3 years of Safety/Pharamacoviliance Data experience
- Electronic Submissions Module
- MS Excel, MS Outlook, MS Word
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges