*Qualified candidates must reside in Metro Atlanta, GA

SUMMARY

The Drug Safety Associate (DSA) is responsible for the day-to-day processing of Adverse Event (AE) and Product Complaint (PC) cases in the Medical Information Contact Center (MICC). The DSA will collect information related to AEs and PCs and document the information in the appropriate reporting form and database. The DSA will provide general support for the MICC, as well as other responsibilities supporting the department.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Perform initial intake of AE/PC cases that are directed to the MICC by phone, fax, email, mail, directly from client representatives, and any other means
Write a detailed AE narrative that includes medical history and description of the events
Perform AE and PC follow-up as required by individual clients
Document casework in IRMS proficiently
Utilize client database for AE case processing where required
Generate and maintain monthly/weekly/periodic AE/PC reporting for clients as needed
Perform literature report searches
Serve as backup for Medical Information Contact Center Specialist team as case volume allows
Handle miscellaneous projects within the MICC

QUALIFICATIONS

Nursing degree, Licensed Practical Nurse (LPN)
Current LPN License
Medical Information Call Center and/or Triage experience a plus
Successful candidate should have at least 2 years of experience in family medicine, internal medicine, or urgent care
Pharmacy background preferred
Proficient understanding of US FDA pharmacovigilance regulations as well as client SOPs
Strong scientific writing skills and ability to document accurately
Strong communication skills (oral/ via phone and writing with AE/PC reporters
Must have excellent customer service skills and work well in a fast-paced environment
Proficient in MS Outlook, word processing, Excel, and database entry

The Medical Affairs Company (TMAC)

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