Drug Safety Data management Specialist

Drug Safety Data Management Specialist

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Drug Safety Data Management Specialist

NOTE: CANDIDATES MUST HAVE ARGUS EXPERIENCE.

RESPONSIBILITIES:

• 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.
• 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

Qualifications

QUALIFICATIONS:

• BA degree required with 1-3 years of Safety/Pharamacovigilance Data experience.
• Argus experience.