Drug Safety Data Management Specialist
Artech Information System LLC
Apply to this jobArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
- 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 Argus Electronic Submissions Module (ESM) from European Health Authorities on behalf of company's that are not online with Argus and other submitters as necessary.
- Monitor electronic mailboxes and Argus 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.
- BA degree required with 1-3 years of Safety/Pharmacovigilance Data experience preferred.
BA degree required with 1-3 years of Safety/Pharmacovigilance Data experience preferred.
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3348 | Fax: 973.998.2599
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Summary
Manage safety data, accept reports, ensure coding, and upload data in pharmacovigilance systems.
Job title
Drug Safety Data Management Specialist
Experience level
1-3 years
Industry
healthcare
Location requirements
Morris Plains, NJ, on-site; remote not specified
Salary
Not specified
Visa sponsorship
H-1B sponsor history
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Morris Plains, NJ 07950, USA