Snapshot of the Candidate's Day:
This position will encompass a hybrid role: Supports both PSUR and PMPF processes. As part of the integral 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.S.) for IVDR class A and B products. 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).
How the Candidate Will Make an Impact:
- 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.
- Strong research, writing and communication skills, as well as a solid understanding of scientific concepts.
- Review and analyze scientific literature and summarize findings in applicable protocol reports.
- Maintain, archive and completed controlled quality records.
- Coordinate PMS deliverables with internal business partners.
- Facilitate and/or chair local/regional PMS Board me

📌 Especialista en vigilancia post (México)
🏢 Bio-Rad LAM
📍 México