Job ID 20000HZN
Available Openings 1
Position Specific Information NxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals. If you share our mission and are committed to improving the lives of renal patients, then we invite you to explore our career opportunities .
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 obtain detailed information regarding incidents received by the company and maintain patient confidentiality
- Evaluate device adverse event reports and drug reactions to assess seriousness, expectedness, and relationship
- Determine necessary follow-up for missing, discrepant or additional information/source documentation for each case using product and regulatory knowledge
- Complete Reportability Assessments and Clinical Assessments in a timely manner with full adherence to NxStage policies and procedures outlining complaint handling functions
- Prepare serious, related medical device reports and serious, unexpected adverse drug reactions for expedited reporting according to global regulatory requirements, and company policies and procedures
- Recognize when issues or trends occur and escalate to management as the situations arise
- 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)
- Integrate relevant clinical information into the clinical case narrative to ensure a consistent database record for reports and queries
- 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.
- 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 composing 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 a bonus 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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