Medical Reviewer IV (19-00925) – WA – Bothell

Summary: *** is seeking a Medical Reviewer to perform the assessment of ICSR cases. The Medical Reviewer serves as a primary reviewer of serious adverse events, including SUSARs, for clinical and post marketed products; unbinding of clinical cases during medical review; preparation & creation of analysis of similar events). Job responsibilities: Evaluates cases for seriousness, relatedness, and expectedness according to the protocol. Confirms presence of adequate information needed to perform case evaluation, reviews relevant source documents for consistency and verification of adverse event data. Review narratives in Argus and CSR narratives. Compliance with US, ICH and EU PV and GCP regulations.Qualifications: A physician (MD or equivalent). 8-10 years of pharmaceutical experience preferably performing Medical Review. Ability to critically evaluate safety data from multiple sources (clinical trials, literature, etc.), assesses clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communication is required. Demonstrated qualities of competency, accountability, initiative, and leadership Experience in process improvement initiatives. Extensive knowledge of US, ICH and EU PV and GCP regulations Excellent strategic decision-making and analytical skills Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint Strong leadership skills with excellent track record. Experience with Regulatory Authority Inspections (PV and GCP). Experience working with vendors.
Source: Job Diva – Job Listing

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