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Principal Post Market Surveillance Specialist (Clinical) - NxStage

Lawrence, Massachusetts
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Job ID 19000I5J

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.



SUMMARY:

The incumbent must be a licensed member in good standing with a health care profession such as nursing, pharmacy or medicine. 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 thorough experience in post-market regulations and requirements for medical devices and medicinal products, with an extensive understanding of complaint handling investigations and adverse event follow up.


SPECIFIC RESPONSIBILITIES:

·Review all clinical complaints received by NxStage 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 medical, 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

·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

·Author, contribute, and coordinate Health Risk Assessments, patient safety meetings, safety summaries for annual reports, and other 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



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 the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Office environment


Requirements:

·Registered Nurse or other qualified healthcare professional in good standing within their association

·2 – 5+ years clinical experience within their healthcare profession

·2 – 5+ years of work experience within 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

·Exceptional attention to detail and strong organizational skills

Attributes:

·Proficient in the use of Microsoft Office programs, specifically Excel, PowerPoint, Word

·Approachable, positive attitude and willing to act as a mentor for others as required

·Critical thinker with meticulous decision-making capability

·Strong 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