Drug Safety Data Management Specialist

Artech Information System LLC; Morris Plains (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading IT staffing company is seeking a Technical Recruiter for Safety/Pharmacovigilance Data roles. The position involves entering safety information into databases, coding events, and ensuring timely handling of reports. A BA degree and 1-3 years of experience in related fields are required. The role offers a chance to work in a dynamic environment and contribute to critical data management efforts.

Qualifications

• 1-3 years of Safety/Pharmacovigilance Data experience preferred.
• Experience in electronic data handling.
• Familiarity with quality check processes.

Responsibilities

• Enter information into global safety database.
• Accept and monitor E2B cases from health authorities.
• Ensure proper coding of events and drugs.
• Upload AE reports on behalf of country offices.

Skills

Data Entry

Coding of events and drugs

Quality Check

Education

BA degree

Tools

Argus ESM

Job description

Artech 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.

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 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.

Qualifications

BA degree required with 1-3 years of Safety/Pharmacovigilance Data experience preferred.

Additional Information

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3348 | Fax: [phone]

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