POSITION: Medical Safety Specialist
FULLTIME/PARTTIME: FULLTIME
LOCATION: Remote or Hybrid Marlborough, MA
SCHEDULE: 8am – 4:30pm
PAY RANGE: $35.00 – 38.46 hourly
(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)
ASSIGNMENT: 12 months
JOB DESCRIPTION:
- Role manages surveillance processes across a wide range of coronary artery disease states.
- Completes accurate, timely, and consistent medical assessment of adverse events and potential adverse events in order to provide medical expertise, objective oversight and ensures safety vigilance throughout the total product lifecycle.
- Major interfaces include Clinical, Regulatory, Quality, Post Market Surveillance, Complaint Management Center and functional management.
- Performs work under limited supervision of the Medical Safety Manager/Medical Director.
JOB RESPONSIBILITIES:
- Applies knowledge and experience of clinical medicine to a wide range of medical devices in one or more therapeutic areas.
- Receives and analyzes data from multiple sources (clinical trials, complaints, Medical Device Reports, etc.), identifies safety issues, and participates in trend analysis for input into internal and external Medical Safety reports.
- Escalates potential patient safety issue for decision-making and/or potential action by senior leadership.
- Represents Medical Safety at multi-functional team meetings.
- Works closely with Medical Director and Manager to produce clear and concise communication of complex data.
- Seeks opportunities for continuous quality improvement.
- Applies working knowledge of medical device regulations and standards (globally), including EUMDR and EUDAMED
REQUIRED QUALIFICATIONS:
- Bachelor's degree or equivalent in healthcare/life science related field
- 2+ years of direct patient care experience required. Examples of health-related field professionals include but
are not limited to registered nurse, physician’s assistant, and nurse practitioners - Direct patient care in Cardiology preferred
- 2+ years of experience in clinical/scientific research, preferably with medical device clinical trials preferred
- Post Market Surveillance experience preferred