PURPOSE AND SCOPE:

Seasoned, experienced professional, responsible for receiving, reviewing, and processing all product inquiries and Adverse Event, Near Miss Events, FKC related to patient care issues, medical devices and pharma products. Provides customer support and serves as a resource to internal and external customers. Partners with members of the Safety Department and organization regarding Clinical Services resource issues.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Under limited supervision, supports all Patient Safety Department initiatives.

• Monitors and audits the company's Safety and product surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in compliance with state, government regulations and timelines.

• Ensures accurate receipt, maintenance and assessment against efficacy and product indication in collaboration with key stakeholders, Technical Services, Biomedical Engineering, Medical Office etc.

• Creates and provides clinical information and safety reports as required by regulatory agencies. May provide trending and safety signal detection and assessment within the scope of the Clinical Services day to day business.

• Keeps abreast of all applicable rules and regulations. May support clinical trial activity, post marketing safety surveillance, and adverse event collection and reporting.

• Works closely with Patient Safety Department leadership, to establish weekly/monthly performance metrics.

• Provides training to staff and other resources across Fresenius Kidney Care/Clinical Services on Patient Safety Surveillance activities as required.

• Uses critical thinking and high-level thought process skills related to work product.

• Works on problems of difficult to 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.

• Acts as a resource for Customers and Patients to address concerns and questions.

• Assists in oversight and execution of secretarial and administrative functions.

• Works collaboratively with all Clinical Services department as necessary.

• Maintains official department and other relevant records and executed administrative policies.

• May prepare memos and correspondence outlining and explaining policies.

• Collects, compiles, and analyzes complex information as required.

• Interfaces with a variety of senior management across organizations and with external customers.

• Assists with various high priority department deliverables.

• Monitors the department Resource line, provides excellent customer service and field clinical services support.

• Oversees the Interface with Customers to gather additional information required for complaint initiation/investigations, including the retrieval of medical records, treatment sheets etc related to the reported event.

• Works collaboratively with the department management to lead complaint investigations.

• Ensures complaints from multiple sources (i.e. verbal, fax, Clinical Services Resource Line, Patient Grievance Line, Compliance Action Line (CAL) etc.) are entered into the appropriate tracking tool.

• Responsible for the oversight of receiving, reviewing, and entering data into the tracking tool regarding customer/patient product inquiries and complaints using good documentation practices (GDP).

• Identifies, communicates and facilitates appropriate escalation related to critical issues.

• Notifies customer of receipt of product inquiry/complaint and provides preliminary support as needed.

• Prepares other customer communication (response letters, acknowledgement letters) as appropriate.

• Partners with Operations, Marketing, Education, Biomedical and other departments to resolve product problems and provides feedback to customers as needed.

• Oversees and assists with review of the timely completion of investigations, closure of all resource line files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure.

• Builds productive working relationships.

• Escalates issues to supervisor/manager for resolution, as deemed necessary.

• Performs other related duties as assigned.

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.
• This position requires approximately 10% travel.

SUPERVISION:

• None

EDUCATION AND REQUIRED CREDENTIALS:

• Current unrestricted license as an RN-Registered Nurse.
• Bachelor's degree in Nursing, healthcare preferred.
• Advanced degree desirable.
• Certification in Nephrology Nursing preferred.

EXPERIENCE AND SKILLS:           

• 5 - 8 years' related experience in clinical dialysis healthcare; or a Master's degree with 3 years' experience; or equivalent directly related work experience.
• Previous clinical dialysis experience strongly preferred.
• Prior experience processing medical device or drug complaints strongly preferred.
• Knowledge and understand of medical terminology.
• Exemplary Customer Service, interpersonal, collaboration and relationship skills.
• Proficient computer skills essential; web-based collaboration and document management platform, Microsoft Office and Visio.
• Excellent communication skills-verbal and written.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.