Eproduct Surveillance Analyst Resume
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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 .