Product Complaint Analyst I

Purpose

Individual will work in AbbVie’s global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal and external AbbVie customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding AbbVie product complaints. Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events.

Responsibilities

• Assure complaint records meet global requirements.
• Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related event.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
• Identification of potentially reportable events and notification to appropriate fun...