Fresenius Medical Center Post Market Surveillance Specialist in Waltham, Massachusetts
PURPOSE AND SCOPE:
Responsible for receiving, reviewing, and processing all product inquiries and product complaints for manufactured and distributed products (equipment, drug, and device) as required by applicable regulations, standards, and company policy. Helps provide customer support and serves as a liaison between manufacturing facilities, distribution centers, customer/technical service, and customers/patients regarding product complaints. Partners with Pharmacovigilance resources on any possible adverse event (MDR/ADE) or reportable complaints, as well as with Corporate Quality Engineering on product investigations and trends.
PRINCIPAL DUTIES AND 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. 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).
Normally receives general work instructions on routine work, detailed instructions on new projects or assignments.
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.
Applies knowledge of drug/device regulatory requirements in order to support the Post Market Clinical Surveillance MDR/ADE reporting process and evaluates complaints for MDR reporting utilizing product knowledge and Decision Trees.
Evaluates complaints for Field Alert Reporting (FAR).
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.
Processes basic submissions of MDR/ADE decision trees and refers complex MDR/ADE draft assistance to senior staff.
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 processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality.
Builds productive working relationships.
Escalates issues to supervisor/manager for resolution, as deemed necessary.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Assists with various projects as assigned by direct supervisor.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS :
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s Degree required, preferably in a healthcare related field. Associate’s Degree may be considered with additional years of relevant experience.
EXPERIENCE AND REQUIRED SKILLS:
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 required; with an Advanced Degree no prior experience may be considered.
Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).
Prior experience processing medical device or drug complaints strongly 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.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity