Fresenius Medical Care Job - 35465216 | CareerArc
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Company: Fresenius Medical Care
Location: Waltham, MA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech


Job ID 20000JFQ

Available Openings 1


Subject Matter Expert supporting the implementation and coordination of the Clinical Services Resource line, Patient Grievance Line and works closely with the Compliance Department on Compliance Action Line (CAL) investigations. Leads day to day operations for all adverse event investigations and partners closely with the Legal, Department, Medical Office, Clinical Staff, Biomedical Engineering Department and others as needed in providing field support and communication. Maintains critical, collaborative relationship with Regulatory Affairs, Medical Office, Clinical Services, Clinical Operations, and Clinical Education and Quality. Works closely with Patient Safety and Clinical Services Leadership in support of the Patient Safety program. Provides informal leadership in developing a culture of safety, as well as in identifying opportunities and initiatives to enhance patient safety. Supports strategic and operational plans that build upon the present Patient Safety Program.


  • Provides SME and participates in the day to day Patient Safety Department Operations to ensure the operations effective achievement of goals within the assigned business unit.

  • Coordinates activities with the appropriate interdisciplinary teams in corporate, field staff, or operations related to serious events, medical device complaints/problems, human resource and interdivisional and interdepartmental problems that affect clinical operations and outcomes. Provide direction to facilities regarding completion of required reports collaborating with Corporate Law Department and Risk Management as necessary.

  • Reviews health records as necessary to assess and evaluate the appropriateness of care and treatment.

  • Assists clinical management and staff with understanding and maintaining compliance with ESRD regulatory requirements including Subpart U-conditions of coverage, Federal and State regulations.

  • Assists facilities in the implementation of annual Safety and Clinical Services Department initiatives such as, Influenza Vaccine Program, 5 Diamond Program, Hand Hygiene and Hepatitis initiatives.

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

  • Acts as a clinical resource to facilities, area and regional management, and corporate staff and physicians collaborating with the pertinent Regulatory Affairs staff, Education staff, Technical Services, Renal Therapies Group and other company groups to ensure the appropriate interpretation and adherence to company compliance and other department policies, to assist in identifying potential areas of non-compliance and to communicate identified problems and compliance initiatives to the field.

  • Assists in resolving legal and litigation issues with the goal of diminishing expenses to the Company.

  • Assists in the development of business integrity related policies and procedures.

  • Develops educational materials and audit tools for Clinical and Corporate staff.

  • Develops quality improvement plans when expected clinical outcomes are not met.

  • Guides clinical practice via program development utilizing training manuals and other educational materials, consultation, review of current literature etc.

  • Develops clinical policies and procedures related to machine technology used in facilities.

  • Identifies data elements for use in future clinical quality programs, initiatives, policies and procedures.

  • Assists the Medical Record Management Department to develop policy and training programs related to Clinical Quality.

  • Contributes to ensuring quality of care for all home patients by providing input to Home Therapy policies and procedures.

  • Addresses product issues and selection and to develop procedures for FDA approval for new products and product changes.

  • Provides guidance, interpretation and subject matter expertise to the organization regarding inquiries about clinical policies and procedures, clinical standards, as well as professional practice.

  • Maintains key relationships with Value Based Services Support Departments and Leads, Medical Department, Education Department, Technical Services Department, Legal and compliance Departments, Operations Leadership.

  • Provides assistance to staff with complex tasks that require considerable judgment and initiative.

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

  • Performs other related duties as assigned.


  • 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 20% travel.


  • None


  • Current unrestricted license as an RN-Registered Nurse.

  • Bachelor's degree in Nursing, healthcare preferred.

  • Advanced degree desirable.

  • Certification in Nephrology Nursing preferred.


  • 8 – 12 years' related patient care experience in a clinical dialysis setting; or a Master's degree with 6 years' experience; or equivalent directly related work experience.

  • 2+ years' experience as a Clinical Manager preferred.

  • Certification in Patient Safety desired.

  • 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.

  • Ability to prioritize and manage multi-dimensional health care related activities.

ADDENDUM: Pharmacovigilance  Collaborates with internal and external partners to manage medication/pharma-related surveillance activities.  Prepares, participates and responds to audits and assures audit readiness.  Maintains compliance with manufacturer agreements.  Maintains and investigates adverse events related to medication safety.  Reports medication adverse events to manufacturers and Medical Office.  Identifies and assists with medication safety initiatives. EXPERIENCE AND SKILLS:  Knowledge and experience with drug safety/pharmacovigilance environment within the healthcare industry.  Familiar with adverse drug event reporting to manufacturers and FDA requirements.

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.

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