Address
Form of work Job Title: Assoc MDR/Vigilance Specialist
Job ID: 12234
Location: Mounds View Minnesota 55112
Duration: 24 Months Contract
Top 3 things the manager is looking for:
MDR Experience
Previous healthcare experience
Med device company experience
Top 3 Tasks in Scope for this role:
Review incoming complaints from the field
Go back out to the field for further information on complaints
File regulatory reports
Location: Mounds View, MN Onsite work Wednesday and Thursday.
Hours: 40
Responsibilities may include the following and other duties may be assigned.
Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Must Have: Minimum Requirements
Bachelors degree required
0 years of experience required
Spoorthi Raj G
Associate Recruiter
Office: 973-604-7303
Email: Spoorthi.G@Artech.com
Website: www.artech.com
https://www.linkedin.com/in/spoorthi-raj-g-24254222b/
Job ID: 12234
Location: Mounds View Minnesota 55112
Duration: 24 Months Contract
Top 3 things the manager is looking for:
MDR Experience
Previous healthcare experience
Med device company experience
Top 3 Tasks in Scope for this role:
Review incoming complaints from the field
Go back out to the field for further information on complaints
File regulatory reports
Location: Mounds View, MN Onsite work Wednesday and Thursday.
Hours: 40
Responsibilities may include the following and other duties may be assigned.
Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Must Have: Minimum Requirements
Bachelors degree required
0 years of experience required
Spoorthi Raj G
Associate Recruiter
Office: 973-604-7303
Email: Spoorthi.G@Artech.com
Website: www.artech.com
https://www.linkedin.com/in/spoorthi-raj-g-24254222b/
