Medical Reviewer/Safety Reviewer Job in North Chicago 60064, Illinois US
Medical Reviewer/Safety Reviewer
Abbott Park, IL
Responsibilities include medical review, which involves in-house review of paper and electronic Case Report Forms (CRFs), including query issuance and resolution; QA, safety review and analysis of serious and non-serious adverse events; and of vital sign, ECG, and laboratory data. Interacts and collaborates with cross functional Clinical Team, and external sites on management of clinical trial safety data. Provides medical support of, and close collaboration with, the study Medical Monitors, which includes: the analysis and exploration of investigational product adverse events and other safety data. Responsibilities also include protocol review and input; study team participation, issue identification and resolution, and completion of safety narratives for Clinical Study Reports. Responsibilities may include working with Medical, Clinical, and Regulatory Affairs in the preparation of documents on adverse events for regulatory reporting purposes; and may also include provision of ad hoc training internally and to investigative sites on safety reporting requirements, including CRF completion. Strong organizational, communication, and analytical skills required. Strong Microsoft Office skills needed. 5+ Years Experience Level. Licensure as a Registered Nurse and a strong Pharma/Research and Development background are required for this position. Background in Drug Safety/Pharmacovigilance or Clinical Trial oversight is highly desired.
Licensure as a Registered Nurse and a strong Pharma/Research and Development background are required for this position. Background in Drug Safety/Pharmacovigilance or Clinical Trial oversight is highly desired.
Please respond by sending your resume to rahul.k@ustechsolutions.com / garima@ustechsolutions.com