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Senior Medical Safety Specialist - Remote / Telecommute

$87k+
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Full-time
Remote
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Job Description:

Responsibilities:
  • Applies knowledge and experience of clinical medicine to a wide range of medical devices in one or more therapeutic areas including but not limited to Candidates Health (gynecological surgery, pelvic organ prolapses, urinary incontinence), Candidates Health (erectile restoration, urinary incontinence), Prostate Health (benign prostatic hypertrophy), and Stone (urinary tract stones).
  • Performs medical reviews and assessments of adverse events from multiple sources which include clinical trials, complaints, and Medical Device Reports; identifies safety issues; and potential safety signals.
  • Performs pre-scheduled and ad hoc analyses of data from multiple sources and presents data by communicating accurate, succinct summaries at team and cross-functional meetings.
  • Represents Medical Safety at multi-functional team safety trend meetings.
  • Works closely with the Medical Director to produce clear and concise communications of complex data.
  • Effectively escalates potential patient safety issues for decision-making and/or potential action by senior leadership.
  • Provides medical safety support to maintain risk documentation for existing products and helps develop risk documents for new products in development.
  • Applies medical device regulations and standards appropriately (globally).
  • Supports team in internal and external audits.
Minimum Qualifications:
  • Bachelor's level degree or equivalent in healthcare/life science-related field.
  • 5 + years of direct patient care experience or experience in a healthcare setting is required.
  • Examples of health-related field professionals include but are not limited to registered nurse, physicians assistant, and nurse practitioners.
Preferred Qualifications:
  • Familiarity with or experience in urology disease states.
  • Post Market Surveillance experience preferred.
  • Ability to manage complex projects.
  • Excellent oral, written and computer skills required.

Last updated on Sep 19, 2023

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