Fresenius Medical Care Job - 38118075 | CareerArc
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Company: Fresenius Medical Care
Location: Lawrence, MA
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job ID 210003G6

Available Openings 1

PURPOSE AND SCOPE:

This person is responsible for reviewing clinical and product complaints for patient safety events, adverse events, serious adverse events, adverse drug reactions and serious adverse drug reactions to assess for reportability in compliance with global medical device and pharmacovigilance regulations. They are responsible for activities associated with clinical investigations for device and medicinal product related complaints and adverse events. The candidate must have experience in post-market regulations and requirements for medical devices and medicinal products, with a solid understanding of complaint handling investigations and adverse event follow up.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Review all assigned clinical and product complaints for medical device events and drug related incidents
  • Interface with customers and clinical staff to acknowledge, document and obtain detailed information regarding adverse events and incidents received by the company
  • Apply knowledge of medical device and drug regulatory requirements to support the reporting decision process and identify reportable events as they are received
  • Complete Reportability Assessments and Clinical Assessments in a timely manner with full adherence to NxStage policies and procedures outlining complaint handling functions
  • Integrate relevant clinical information into the clinical case narrative to ensure a consistent database record for reports and queries
  • Prepare and submit medical device and drug reports according to global regulatory requirements, company policies and procedures
  • Identify possible trends related to clinical complaints and present information or concerns to management using available programs and applications (e.g. PowerPoint, Excel, BIRST, Minitab, graphs, charts)
  • Recognize when issues or trends occur and escalate to management as the situations arise
  • Assist with writing Health Risk Assessments, presenting at patient safety meetings, compiling safety summaries for annual reports, and other input into safety reports as needed or requested
  • Perform periodic literature and online database searches per NxStage processes and to identify current industry trends, risks, harms and hazards

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.

EDUCATION:

  • Bachelor's Degree in a healthcare related field. An Associate Degree may be considered with additional years of relevant experience

EXPERIENCE AND REQUIRED SKILLS:

  • Minimum 5+ years of work experience processing complaints within the device and/or pharmaceutical/life-sciences industry
  • Demonstrated knowledge of global medical device and/or pharmacovigilance regulations
  • Experience with FDA and international device/drug reporting requirements
  • Excellent written, verbal & interpersonal communication skills
  • Proficient in the use of Microsoft Office programs, specifically Excel, PowerPoint, Word
  • Approachable, positive attitude and willing leadership abilities for mentoring for others as required
  • Critical thinker with meticulous decision-making capability
  • Exceptional attention to detail in documenting events, composing clinical narratives and editing quality documents
  • Demonstrated ability to manage multiple competing priorities and meet deadlines
  • Ability to work independently and as a team player
  • Experience using a global complaint handling database or quality management system e.g. CATSWeb and Agile

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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