Job Description: Client has an urgent need to hire a strong PSUR writer who can step in and hit the ground running with minimal hand holding. Need to be able to gather and analyze the data for the PSUR and put it into a document that tells a story. Good news is that the DQE’s at the site have been updating the risk management files and as they do that they are re-coding the complaints with the IDEF codes so that has helped for cleaner data for this resource to be able to analyze and in turn be able to write a clear PSUR. Consultant will have to do high level analysis of the data, look at the spikes/dips and tell that story in the document. Need candidates who have written the PSUR beginning to end and have a good understanding of how it fits into the regulatory landscape. This is a hunt down the info job and experience with gathering data from public databases like TDA, MHRA, etc are required.
Skills: PSUR, Writing/Authoring, Data Analysis
Education: B.S. Degree is a MUST, M.S. is Preferred.
Remote: PSUR Consultant (233237)
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