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Eproduct Surveillance Analyst  Resume

Boston

SUMMARY:

Dedicated professional with diverse experience, education, and technical eptitude in the healthcare industry. I have a proven background of strong communication, adaptive learning, and leadership skills in a high - stress environment.

EXPERTISE AREA:

  • Medical and Technical Writing
  • Research writing
  • Supervisory experience
  • International communicationTraining Material Development
  • Audience Content Development and Implementation
  • Proofreading
  • Articles & Publications
  • Social Media
  • Remote Project Management
  • Team Building Projects

PROFESSIONAL EXPERIENCE:

EProduct Surveillance Analyst

Confidential, Boston

Responsibilities:

  • Research and process electronic medical device events for complaint status and Confidential reportability determination.
  • Understanding of International regulatory concerns and direct communication with foreign business contacts.
  • Regular use of the Trackwise reporting tool for assessment and reporting of device complaints.
  • Able to make decisions in a timely manner and meet specific deadlines.
  • Conduct follow-up for complete and accurate event details
  • Organize and maintain workload using Excel to ensure the efficient and fluid processing of all tasks.
  • Participated in training of a new contract employee using my own, newly developed training powerpoint.

Assoc. Clinical Research Specialist

Confidential

Responsibilities:

  • Provide support to multiple clinical research clients and medical sites throughout varying stages of a pharma clinical trial.
  • Provide regular communication to all of our global partners.
  • Created a service brochure for the Cardiac Monitoring Clinical Research dept as it pertains to the SEEQ monitoring device (rough draft available - marketing dept adjustments pending)
  • Created a detailed written document comparing the capabilities of the SEEQ device to a holter monitor.
  • Perform aftrial fibrillation calculations for client/patient follow-up
  • Manage multiple databases for tracking patient and client information.
  • Manage the shipping and returns of all SEEQ monitoring equipment
  • Communicate regularily with internal and external stakeholders to ensure fluid operations between all factions of the study team.

MDR Specialist

Confidential, Moundsview, MN

Responsibilities:

  • Research and process electronic medical device events for complaint status and Confidential reportability determination.
  • Understanding of International regulatory concerns and direct communication with foreign business contacts.
  • Experience working with the International MDR Team - responsible for making reportability decisions through the collaborative efforts of Confidential personnel from outside of the United States.
  • Able to make decisions in a timely manner and meet specific deadlines.
  • Conduct follow-up and gather pertinent information used to “piece together a puzzle” by utilizing clinical or internal resources relative to the event.
  • Organize and maintain files using Access and Excel to ensure the efficient and fluid processing of all tasks.
  • Ensure the quality and accuracy of each event the first time by learning from mistakes and moving forward.

Clinical Applications Specialist

Confidential, Minneapolis, MN

Responsibilities:

  • Provide on-going, client support for health care information systems software (Medical Practice Management.)
  • Create written updates and instructions for customers using simple and easy to follow directions.
  • Update documentation as processes and procedures change.
  • Write step-by-step instructions on how to reproduce any issue reported by a customer for programmers, developers, and client specialists.
  • Facilitate role as first point of contact for the customer core team consisting of doctors, nurses, IT and IS professionals, Super Users, clinic and hospital administrators.
  • Delegate tasks to a variety of specialties such as billing support, support programming, development, and several specialty groups nationwide.
  • Participated in the implementation of a Google intranet site created specifically for the Clinical Client Services department for Confidential .
  • Conduct multiple weekly conference calls with the customer core team, including WebEx demonstrations and education webinars.
  • Proven ability to carry a very high task-load with strict deadlines.

Confidential

Responsibilities:

  • Obtain information pertaining to all medical or traumatic emergencies for immediate relay to hospital physicians, specialists, and nursing staff.
  • Document all patient encounters for comprehensive understanding of all emergency calls by “painting a picture” of the incident.
  • Responded to an estimated 9,000 calls over the course of my career
  • Practice strict safety procedures as it pertains to handling of patients and medical eq uipment
  • Anticipate and prepare for any situation that may compromise scene safety

Contract Columnist

Confidential

Responsibilities:

  • Wrote fora bi-monthly column with the objective to help emergency responders develop tailor-made health habits while working in a high stress and physically demanding environment.
  • Wrote Article named “ Confidential ”, used as course material for the Confidential .

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