Post Market Surveillance Specialist 1

Post Market Surveillance Specialist

Responsibilities:

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Interfaces with Customer Service and customers/patients to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation.
• Ensures that complaints from multiple sources (i.e. email, phone, verbal, fax, etc.) are entered into the complaint database.
• Responsible for receiving, reviewing, and entering data into the Compliant Management Database regarding customer/patient product inquiries and complaints using good documentation practices (GDP).
• Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.
• Ensures that durable Equipment CRM Technical Service reports are correctly identified as to status for transfer into system.
• Determines product and incident complaint codes based on the master symptom code severity list.
• Notifies customer of receipt of product inquiry/complaint and provides preliminary support as required.
• Prepares other customer communication (response letters, acknowledgement letters) as appropriate.
• Partners with sales, marketing, and manufacturing departments to resolve product problems and provides feedback to customers as needed.
• Assists with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure.
• Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
• Interfaces with Corporate Quality Engineering and the RTG manufacturing sites as required for product investigations/trends.
• Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements.
• Strives to meet Accuracy Goals (95% accuracy goal). Ensures data is collected through routine business

Qualifications:

• Bachelor's degree preferred, preferably in a healthcare related field.
• Minimum 2 – 5 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations; understanding of drug/device safety requirements are preferred; with an Advanced Degree no prior experience may be considered.
• Prior experience processing medical device or drug complaints preferred.
• Strong interpersonal skills.
• Knowledge based PC computer skills essential, such as industry recognized complaint management systems, crystal reporting, MS Access and Excel.
• Familiarity with medical terminology is preferred. 
• Bilingual (English/Spanish) Fluent in English.