Medical Reviewer/Safety Reviewer - B

Experience in either of these areas is helpful. Reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols.
Reviews and follows-up on Serious Adverse Event (SAE) information in order to fulfill timely reporting according to the authority/regulatory requirements.
Participates in applicable safety surveillance activities for assigned products.
Reviews and analyzes Adverse Events (AE) including SAEs being reported to IND safety.
May include assessment of AE coding for consistency and accuracy of coding.
Medical review of safety-related Clinical Report Forms and labs, including communication with Study Physicians.
Interface with study manager, CROs, CRAs, Data Management, PV to assure query resolution.
Creation of narratives for SAEs and other identified AEs of interest in accordance with accepted standards and with minimal revision required upon review.
Broader knowledge of ICH/FDA regulations and guidelines affecting drug safety issues preferred.
Computer proficient (Windows, Word, Excel).
Able to present adverse event data, orally and in writing.
Type:Temp/ContractLocation:North Chicago, IL

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