Medical Device Product Safety Analyst - Entry/Junior Level
Planet Pharma, Minneapolis, MN, United States
***PLEASE NOTE: THIS ROLE REQUIRES
ONSITE WORK 4 DAYS/WEEK ***
Our client, a leading Medical Device company, is seeking an entry/junior level Product Safety Analyst. This role is ideal for someone who recently completed a Bachelor\'s Degree and has an interest in the medical device field (there is a robust training. See below for other details:
Responsibilities
Apply policies and procedures to comply with FDA and OUS regulations.
Monitors the company\'s drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
Maintain awareness of new products, government regulations and requirements.
Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
Other duties as assigned.
Requirements
Bachelor\'s Degree within some type of Science (Biology, etc) or Biomedical Engineering
0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Have
Degree in Health Care, Sciences, or Bio-Medical Engineering
Medical device industry experience
Strong verbal and written communication skills
Knowledge of basic anatomy and physiology
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ONSITE WORK 4 DAYS/WEEK ***
Our client, a leading Medical Device company, is seeking an entry/junior level Product Safety Analyst. This role is ideal for someone who recently completed a Bachelor\'s Degree and has an interest in the medical device field (there is a robust training. See below for other details:
Responsibilities
Apply policies and procedures to comply with FDA and OUS regulations.
Monitors the company\'s drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
Maintain awareness of new products, government regulations and requirements.
Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
Other duties as assigned.
Requirements
Bachelor\'s Degree within some type of Science (Biology, etc) or Biomedical Engineering
0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Have
Degree in Health Care, Sciences, or Bio-Medical Engineering
Medical device industry experience
Strong verbal and written communication skills
Knowledge of basic anatomy and physiology
#J-18808-Ljbffr