Medical Complaint Specialist (19-00949) – TX – Fort Worth

Responsible for day-to-day case management of quality technical and adverse event complaint records, including intake, customer communications, triage and system entry, involving *** device products. Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives.Receive initial complaint from any source (ECPs, patients, internal *** personnel) and assure all information/data is accurately captured at point of contact.•Maintain an understanding of information/data required to be collected for technical and AE complaints to assure compliance with regulations and directives.•Manage technical and adverse event complaint records for assigned area(s) using designated safety system(s).•Review potential complaint data received via safety system(s) and other methods, as required.•Is cognizant of, and works efficiently within applicable time zones.•Performs intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per requirements and directives.•Performs data entry for affiliates without access to safety database(s).•Triage call from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit.•Reviews data entry and follow-up activities for completeness and timeliness.•Closes files according to established guidelines to meet required timelines.•Maintains a working knowledge of company policies and procedures, departmental processes, and associated work instructions.•Involved with local and international regulations, guidelines and applicable directives on *** products for assigned therapeutic area(s) and corresponding documentation (Product Inserts, DFUs, Manuals, Promotional Materials).•Understands terminology and abbreviations regarding eye anatomy, common diseases, and ophthalmic procedures.•Utilizes safety databases(s) and reporting tools.•Informs management of potential safety issues, emerging trends and/or concerns.
Source: Job Diva – Job Listing

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