Planet Pharma
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Medical Safety Reviewer III
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Planet Pharma Continue with Google Continue with Google 2 days ago Be among the first 25 applicants Join to apply for the
Medical Safety Reviewer III
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Planet Pharma Get AI-powered advice on this job and more exclusive features. Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Job Description
Pay range: 41-51/hr
depending on experience
Job Description: The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients. Activities performed under this team: Assisting with ongoing continuous improvement projects spanning across departmental needs Responsible for individual and periodic medical device safety reporting Responsible for PI site notifications Providing support for training and automation efforts Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed. Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products. Biomedical engineer or RN Required Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) Experience/Skills: Bachelor’s degree in Nursing required or higher with minimum 3-4 years’ experience in the medical device industry required Minimum 5 years direct patient care as a Registered Nurse preferred Expert level of understanding of global Medical Device regulations such as FDA, EU-MDR and other guidelines affecting
device safety issues Sound understanding and application of device risk management and associated risk management documents such as Clinical Hazards List, Application Failure Mode and Effects Analysis, System Risk Analysis etc. Excellent critical thinking and application skills required Ability to speak up and support medical device safety analytics team in meetings and explain position of the clinical team Able to apply clinical knowledge and expertise to adverse event data and perform safety assessment Competent in ability to present device safety event data, orally and in writing Adheres to policies and regulations Must be Computer proficient (Windows, Word, Excel). Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organize the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Administrative Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Continue with Google Continue with Google Medical Reviewer/Safety Reviewer - Nursing
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Medical Safety Reviewer III
role at
Planet Pharma Continue with Google Continue with Google 2 days ago Be among the first 25 applicants Join to apply for the
Medical Safety Reviewer III
role at
Planet Pharma Get AI-powered advice on this job and more exclusive features. Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Job Description
Pay range: 41-51/hr
depending on experience
Job Description: The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients. Activities performed under this team: Assisting with ongoing continuous improvement projects spanning across departmental needs Responsible for individual and periodic medical device safety reporting Responsible for PI site notifications Providing support for training and automation efforts Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed. Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products. Biomedical engineer or RN Required Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) Experience/Skills: Bachelor’s degree in Nursing required or higher with minimum 3-4 years’ experience in the medical device industry required Minimum 5 years direct patient care as a Registered Nurse preferred Expert level of understanding of global Medical Device regulations such as FDA, EU-MDR and other guidelines affecting
device safety issues Sound understanding and application of device risk management and associated risk management documents such as Clinical Hazards List, Application Failure Mode and Effects Analysis, System Risk Analysis etc. Excellent critical thinking and application skills required Ability to speak up and support medical device safety analytics team in meetings and explain position of the clinical team Able to apply clinical knowledge and expertise to adverse event data and perform safety assessment Competent in ability to present device safety event data, orally and in writing Adheres to policies and regulations Must be Computer proficient (Windows, Word, Excel). Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organize the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Administrative Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Continue with Google Continue with Google Medical Reviewer/Safety Reviewer - Nursing
Elk Grove Village, IL $18.00 - $25.00 1 week ago North Chicago, IL $45.00 - $50.00 8 hours ago Medical Fact Checker (Medical Writer III)
Schaumburg, IL $60,000.00 - $75,000.00 2 weeks ago Algonquin, IL $70,000.00 - $80,000.00 3 weeks ago Security Review Architect (Remote) - Contract Position
North Chicago, IL $45.00 - $50.00 8 hours ago Des Plaines, IL $18.00 - $22.00 4 months ago Security Review Architect (Remote) - Contract Position
Rolling Meadows, IL $98,000.00 - $191,000.00 2 weeks ago Des Plaines, IL $50,000 - $75,000 1 day ago Automotive Service Advisor / Service Writer – Highland Park, IL
Schaumburg, IL $42,000 - $42,000 2 weeks ago Lake Forest, IL $147,300 - $294,700 1 week ago Northbrook, IL $70,000 - $85,000 2 weeks ago Supply Chain Planner (On-site) - Northbrook, IL
Northbrook, IL $85,000 - $92,000 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr