Medical Device Safety - Complaints
Fort Worth Metro Area, TX
- BSN / RN with 3-5 years clinical experience in a medical device setting ophthalmology and or -3 years relevant work experience (i.e. Device/Drug Safety/ Complaint Handling)
- Responsible for day-to-day case management of quality technical and adverse event complaint records, including intake, follow up, triage and system entry, involving medical 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 Adverse event 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
- 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.
- Supports products for assigned therapeutic area(s) and corresponding documentation(Product Inserts, DFUs, Manuals, Promotional Materials)o eye anatomy, common diseases, ophthalmic procedures eye terminology and abbreviations safety databases(s) and reporting tools Informs management of potential safety issues, emerging trends and/or concerns