Job Description

Post Market Performance Follow (PMPF) Analyst

ONSITE M-F start 7-9 flex and end 4-6

1 year contract

$45 /hr

*This position is primarily for the PMPF work but some percentage (potential as much as 49%) could be in the lab depending on workload.

As a PMPF Analyst your activities involve managing and executing post-market follow-up processes. This includes reviewing scientific literature and coordinating with teams such as R&D, Clinical Affairs, Marketing, and RA/QA to collect inputs for Post Market Performance Follow-Up reports. The candidate analyzes clinical studies, marketing evaluations, and published experiences to assess product benefit-risk and draft report conclusions. You will also participate in new product development and sustaining projects, executing studies in the laboratory as required.

How You'll Make An Impact:

• Execute PMPF process and assures tasks are carried out by overseeing the generation and scheduling of Post Market Performance Follow up reports.
• Coordinates PMPFR inputs among cross-functional teams (R&D, Clinical Affairs, Marketing, RA/QA) in order to obtain deliverables responsible for revision of PMPF Plans and PER, as needed.
• Review and analyze scientific literature and summarize findings in applicable protocol reports.
• Guarantee all PMPF deliverables are prioritized, executed and aligned according to the Periodic Safety Update Report Publication timeline.
• Participate in new product development and sustaining projects as required, ensuring all tasks are completed accurately and on schedule.

What You Bring:

• BS in science related field (Biochemistry, Biotechnology, Chemistry or related field)
• 1-3 years of experience
• Skill in addressing situations that need a logical, analytical, and methodical approach
• Knowledge of immunoassays, infectious diseases, bacteriology and related diagnostic techniques/instruments with a minimum of 1 year laboratory experience
• Experience in the in-vitro diagnostics industry preferred with familiarity IVDR regulation 2017/746
• Advance English level: able to communicate effectively in English and in writing
• Proficient use of applications: Word, Excel, Power Point, OneDrive, SharePoint, Teams

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