Especialista en vigilancia post
hace 6 días
This position will encompass a hybrid role: As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts by generating initial post market surveillance (PMS) reports and Post Market Performance Follow Up (PMPF) reports (U.This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The candidate will use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data. QE will work with subject matter experts to analyze product related data and document conclusions of the review activities. In addition, in this role the candidate will be responsible for ensuring Post Market Performance Follow up deliverables are completed in a timely manner (e.g. scientific literature review, post market clinical studies, marketing evaluations, clinical and published experience gained, as well as assessment of product benefit risk and overall report conclusion).
Analysis of post market data and reviewing completed reports with business partners.
Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
Execute PMPF process and assure tasks are carried out by overseeing the generation and scheduling of Post Market Performance Follow up reports.
Maintain, archive and completed controlled quality records.
Facilitate and/or chair local/regional PMS Board meetings.
Support various QMS and PMS projects (local and global) as needed.
Bachelor's degree or equivalent in a related life science/technical/engineering discipline and 5+ years experience in a regulated manufacturing industry or equivalent combination of education.
Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
Understanding of product post market surveillance requirements for IVD products a plus.
Advanced technical writing and word processing skills.
For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products.
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Especialista en vigilancia post
hace 6 días
Juárez, Juárez, Chih., México Bio-Rad LAM A tiempo completoThis position will encompass a hybrid role: As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts by generating initial post market surveillance (PMS) reports and Post Market Performance Follow Up (PMPF) reports (U.This includes regular interactions with area subject matter experts to...
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Especialista en vigilancia post
hace 6 días
Juárez, Juárez, Chih., México Bio-Rad LAM A tiempo completoAs part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating initial periodic product PSURs / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate...
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Especialista en vigilancia post
hace 6 días
Juárez, Juárez, Chih., México Bio-Rad LAM A tiempo completoAs part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating initial periodic product PSURs / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate...
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Especialista en vigilancia post
hace 7 días
Ciudad Juárez, México Bio-Rad LAM A tiempo completoThis position will encompass a hybrid role: As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts by generating initial post market surveillance (PMS) reports and Post Market Performance Follow Up (PMPF) reports (U.This includes regular interactions with area subject matter experts to...
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Especialista en vigilancia post
hace 5 días
Ciudad Juárez, México Bio-Rad LAM A tiempo completoSnapshot of the Candidate's Day: This position will encompass a hybrid role: Supports both PSUR and PMPF processes. As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts by generating initial post market surveillance (PMS) reports and Post Market Performance Follow Up (PMPF) reports...
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Especialista en vigilancia post
hace 2 días
Ciudad Juárez, México Bio-Rad LAM A tiempo completoAs part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating initial periodic product PSURs / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate...
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Especialista en vigilancia post
hace 7 días
Ciudad Juárez, México Bio-Rad LAM A tiempo completoSnapshot of the Candidate's Day: As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating initial periodic product PSURs / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and...
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