Principal Postmarket Surveillance SpecialistApply Now
Location: Lawrence, Massachusetts
Employment Type: Contract
Contract Length: 6 months with possible extension or conversion to perm
Job 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.
- Review all clinical 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 medical, product and regulatory knowledge
- Complete Reportability Assessments and Clinical Assessments in a timely
- 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
- Experience with FDA and international device/drug reporting requirements
- Proficient in the use of Microsoft Office programs, specifically Excel, PowerPoint, Word
- Experience using a global complaint handling database or quality management system a bonus e.g. CATSWeb and Agile
Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.
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