Medical Reviewer/Safety Reviewer II
N Waukegan Rd North Chicago, IL 60064 US
Job Description
*Depending on exp
Experience/Skills
Bachelor’s degree with related health science background is required (e.g. RN, pharmacy experience)
At least 2 years clinical experience is required.
At least 2 years Pharma safety experience preferred.
Competent understanding of ICH/FDA regulations and guidelines affecting drug / device safety issues preferred.
Strong critical thinking skills
Ability to apply clinical knowledge to adverse event data collection and data assessment.
Ability to present accurate and medically sound safety data, both orally and in writing.
Job Description
Reviews and analyzes safety-related data from clinical trials including adverse events.
Timely assessment of adverse event coding for consistency and accuracy of coding.
Timely, accurate and effective medical review of safety-related eCRFs including labs, vital signs, cardiac, medications, medical history, and communicates with Study Lead any findings.?
May participate in safety surveillance activities for assigned studies, including assisting with regulatory responses and ad hoc data analysis
Adheres to regulatory guidance, Protocols, departmental processes and policies under minimum supervision.
Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. 3-5 Years Experience Level.
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