Fresenius Medical Center Associate Post Market Surveillance Specialist in Waltham, Massachusetts
PURPOSE AND SCOPE:
Under close supervision, receives, reviews, and processes routine 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, Post Market Clinical Surveillance and customers/patients regarding product complaints.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Responsible for receiving, reviewing, and entering complaint data into the Compliant Management Database regarding customer/patient product inquiries and complaints using good documentation practices (GDP).
Ensures that reports are correctly identified with regards to status for transfer into the system.
Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Ensures complaints from multiple sources, such as verbal, fax, etc. are entered into the complaint database.
Interfaces with Customer Service and customers/patients to gather additional information required for complaint investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation.
Determines most product and incident complaint codes based on the master symptom code severity list and escalates decisions regarding coding questions to senior staff and/or supervisor/management.
Applies basic knowledge of drug/device regulatory requirements in order to support Post Market Clinical Surveillance MDR/ADE reporting decision process and evaluates complaints for MDR reporting using Decision Trees, as appropriate.
Notifies customer of receipt of product inquiry/complaint if requested and provides preliminary support as required. Refers complex inquiries to senior staff and/or supervisor/manager, as needed.
Prepares other customer communication (response letters, acknowledgement letters), as appropriate.
Responsible for maintaining compliant files within the data base environment using good documentation practices (GDP).
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.
Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements.
Builds stable working relationships internally.
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, healthcare field preferred. Associate’s Degree may be considered with additional years of relevant experience.
EXPERIENCE AND REQUIRED SKILLS:
Minimum 0 – 2 years of related experience.
Learns to understand regulatory requirements within the scope of the department (21 CFR 820.198 and 21 CFR 211).
Strong interpersonal skills and a good communicator
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