Regulatory Affairs Specialist-Pesticides
ustechsolutions4
Contract
Senior Manager Medical Device Safety, Pharmacovigilance
About this role
Company Description
US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website http://www.ustechsolutions.com/.We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you
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Job Description
Title: Senior Manager Medical Device Safety, Pharmacovigilance
Duration: 12 Months
Location: Whippany, NJ 07981
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Job Description:
The Senior Manager Medical Device Safety (MDS) carries out global Pharmacovigilance (PV) business processes and analyses/trends safety data sets related to complaint handling, regulatory reporting and clinical development for Company medical devices and combination products. The Senior Manager MDS is an expert who provides safety oversight and content contributions to design control, clinical evaluations, vigilance reporting to authorities, trending and post-marketing surveillance for Company Pharmaceutical and Consumer Health medical devices and combination products worldwide.
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Position summary:
The incumbent provides counsel as PV medical device subject matter expert to ensure that an effective vigilance, post-marketing surveillance (PMS) and trending systems are implemented and maintained which conforms with global requirements/laws. The Senior Manager MDS works cross-functionally to generate solutions and implement process standards consistent with device industry best practices. The incumbent is a strong problem solver and communicator with a solid understanding of global regulations and standards.
The incumbent will be responsible for the production and accuracy of medical device analysis, interpretation of results and content contributions to PMS and Vigilance activities.
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Position duties & responsibilities:
ā¢ Provide content input to Project teams for designing, planning and conducting analyses of safety data for the assessment of medical device safety and performance.
ā¢ Provide content input to the post-marketing surveillance (PMS) program activities including, PMS system documentation, PMS planning and report management.
ā¢ Provide content input, develop and execute PMS trending methodologies, analysis, written contributions and trend report preparations.
ā¢ Responsible for monitoring, analyzing and applying trending methodologies to the vigilance data submitted to Health Authorities (e.g MDRs).
ā¢ Responsible for the production and accuracy of medical device analysis and interpretation of results.
ā¢ Independently review large data sets and prepare reports for submission the Health Authorities under strict timelines and resolved respective queries regarding product safety.
Qualifications
Requirements/Preferences
Education Requirement(s):
ā¢ Bachelor's Degree in Engineering, Mathematics or Life-science Discipline with 4 years of professional experience in medical devices or similar sector
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Skill & Competency Requirements:
ā¢ Strong scientific application of statistical methods used for evaluating complaint trends and establishing thresholds for routine trend reviews (e.g. human factor, malfunction, user interface and user safety)
ā¢ Background in medical device trending/signal detection and heavy statistical analysis experience.
ā¢ Able to develop and administer management information systems for track and trending.
ā¢ Strong analytical and technical skills that include data collection, analysis and required report generation
ā¢ Strong communication skills and ability to work both, independently and cross-functionally with Quality, Regulatory, Marketing and other applicable functions within the business
ā¢ Working understanding of medical device regulations and industry standards globally specifically 21 CFR 820, 803, ISO 13485, and euMDR 2017/745
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Preferences:
The individual should be comfortable working in both office/virtual settings and independently.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Frequently Asked Questions
Is the salary disclosed for the Senior Manager Medical Device Safety, Pharmacovigilance position at ustechsolutions4?
The salary for this Senior Manager Medical Device Safety, Pharmacovigilance role at ustechsolutions4 is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Manager Medical Device Safety, Pharmacovigilance position at ustechsolutions4 located?
This Senior Manager Medical Device Safety, Pharmacovigilance role at ustechsolutions4 is based in Hanover, Hanover, NJ, United States, NJ, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Manager Medical Device Safety, Pharmacovigilance role at ustechsolutions4 full-time or part-time?
This is listed as a Contract position. It is posted as a Senior Manager Medical Device Safety, Pharmacovigilance role at ustechsolutions4.
How do I apply for the Senior Manager Medical Device Safety, Pharmacovigilance position at ustechsolutions4?
Click the "Apply Now" button on this page. You will be redirected to ustechsolutions4's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Senior Manager Medical Device Safety, Pharmacovigilance job at ustechsolutions4 posted?
This Senior Manager Medical Device Safety, Pharmacovigilance position at ustechsolutions4 was posted on Mar 31, 2020. Apply as soon as possible ā early applications are often reviewed first.
Senior Manager Medical Device Safety, Pharmacovigilance
ustechsolutions4
You'll be redirected to ustechsolutions4's official application page on SmartRecruiters.