Job ID 20000JID
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:
The incumbent 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 will conduct activities associated with clinical investigations for device and medicinal product related complaints and adverse events. The candidate must have a fundamental knowledge of post-market regulations and requirements for medical devices and/or medicinal products.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Review assigned clinical complaints received by NxStage / FMCNA 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
- Collaborate with the clinical postmarket team to assess seriousness, expectedness, and relationship for adverse event reports and drug reactions
- Follow-up with customers or field personnel to gather and collate missing, discrepant or additional information/source documentation for each case
- Complete Reportability Assessments and Clinical Assessments in a timely manner, compliant with regulations and with full adherence to NxStage policies and procedures outlining complaint handling functions
- Assist with preparation of reports for submission according to global regulatory requirements and company policies and procedures
- Integrate relevant clinical information into clinical case narratives to ensure a consistent database record for reports and queries
- Contribute as needed or requested to Health Risk Assessments, patient safety meetings, safety summaries for annual reports, other safety reports and audits
- Perform periodic literature and online database searches as needed per NxStage processes
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.
- Holds a bachelor's degree or studying for same
EXPERIENCE AND REQUIRED SKILLS:
- 2 years of work experience within medical device and/or pharmaceutical/life-sciences industry
- Fundamental knowledge of global medical device and/or pharmacovigilance regulations
- Strong written, verbal & interpersonal communication skills
- Demonstrated ability to meet ongoing concurrent deadlines
- Exceptional attention to detail and strong organizational skills
- Skilled in the use of Microsoft Office programs and other applications
- Ability to think analytically and critically, and to articulate ideas
- Demonstrated ability to manage multiple competing priorities
- Ability to work independently and as a contributing team member
- 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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