Job Description

SUMMARY

The part-time Drug Safety Associate (DSA) is responsible for the 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 to 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 Coordinator team as case volume allows
• Handle miscellaneous projects within the MICC

WORK HOURS: Saturday and Sunday, with some holidays

• This is a remote position with 4-6 weeks required onsite training

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

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