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Experience Level
Senior Level Manager
Qualifications
Education Requirements:Bachelor's Degree in Engineering, Mathematics, or a Life-science Discipline, paired with a minimum of 4 years of relevant experience in the medical device industry or a related field.Skills and Competencies:Expertise in the application of statistical methods for evaluating complaint trends and establishing thresholds for routine trend reviews.Experience in medical device trending/signal detection and proficiency in statistical analysis.Adept at developing and managing information systems for tracking and trending purposes.Strong analytical and technical skills encompassing data collection, analysis, and report generation.Excellent communication skills, with the ability to work both independently and collaboratively across various departments including Quality, Regulatory, and Marketing.
About the job
Position: Senior Manager of Medical Device Safety and Pharmacovigilance
Contract Duration: 12 Months
Location: Hanover, NJ 07981
Job Overview:
The Senior Manager of Medical Device Safety (MDS) is pivotal in executing global Pharmacovigilance (PV) processes. This role encompasses the analysis of safety data pertinent to complaint handling, regulatory reporting, and clinical development for medical devices and combination products developed by the company. As a subject matter expert, the Senior Manager MDS ensures safety oversight and contributes to design control, clinical evaluations, vigilance reporting, and post-marketing surveillance for pharmaceutical and consumer health products globally.
Key Responsibilities:
Offer strategic input to project teams for designing and assessing safety data concerning medical device performance.
Contribute to post-marketing surveillance (PMS) planning, documentation, and report management.
Develop and implement PMS trending methodologies and prepare detailed trend reports.
Monitor and analyze vigilance data submitted to Health Authorities (e.g., MDRs) for compliance and accuracy.
Independently evaluate large datasets and generate reports for timely submission to Health Authorities while addressing any safety-related inquiries.
About US Tech Solutions
US Tech Solutions is a premier global staff augmentation firm dedicated to providing a diverse range of talent on-demand, along with comprehensive workforce solutions. For more information about US Tech Solutions, visit our website at ustechsolutions.com. We actively seek skilled professionals to meet our clients' staffing needs and currently have exciting job openings that might interest you.
Senior Manager of Medical Device Safety and Pharmacovigilance
Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.
Unlock Your Potential
Generate Job-Optimized Resume
One Click And Our AI Optimizes Your Resume to Match The Job Description.
Is Your Resume Optimized For This Role?
Find Out If You're Highlighting The Right Skills And Fix What's Missing
Experience Level
Senior Level Manager
Qualifications
Education Requirements:Bachelor's Degree in Engineering, Mathematics, or a Life-science Discipline, paired with a minimum of 4 years of relevant experience in the medical device industry or a related field.Skills and Competencies:Expertise in the application of statistical methods for evaluating complaint trends and establishing thresholds for routine trend reviews.Experience in medical device trending/signal detection and proficiency in statistical analysis.Adept at developing and managing information systems for tracking and trending purposes.Strong analytical and technical skills encompassing data collection, analysis, and report generation.Excellent communication skills, with the ability to work both independently and collaboratively across various departments including Quality, Regulatory, and Marketing.
About the job
Position: Senior Manager of Medical Device Safety and Pharmacovigilance
Contract Duration: 12 Months
Location: Hanover, NJ 07981
Job Overview:
The Senior Manager of Medical Device Safety (MDS) is pivotal in executing global Pharmacovigilance (PV) processes. This role encompasses the analysis of safety data pertinent to complaint handling, regulatory reporting, and clinical development for medical devices and combination products developed by the company. As a subject matter expert, the Senior Manager MDS ensures safety oversight and contributes to design control, clinical evaluations, vigilance reporting, and post-marketing surveillance for pharmaceutical and consumer health products globally.
Key Responsibilities:
Offer strategic input to project teams for designing and assessing safety data concerning medical device performance.
Contribute to post-marketing surveillance (PMS) planning, documentation, and report management.
Develop and implement PMS trending methodologies and prepare detailed trend reports.
Monitor and analyze vigilance data submitted to Health Authorities (e.g., MDRs) for compliance and accuracy.
Independently evaluate large datasets and generate reports for timely submission to Health Authorities while addressing any safety-related inquiries.
About US Tech Solutions
US Tech Solutions is a premier global staff augmentation firm dedicated to providing a diverse range of talent on-demand, along with comprehensive workforce solutions. For more information about US Tech Solutions, visit our website at ustechsolutions.com. We actively seek skilled professionals to meet our clients' staffing needs and currently have exciting job openings that might interest you.