Location
Columbus, OH | United States
Job description
Job Title: Medical Reviewer/Safety Reviewer - A
Location : Columbus, OH
Duration : 12 Months
Job Description:
- 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 organize 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 reviewing protocols, study summary investigator brochures and IND annual updates for safety data verification.
- 0 to 3 Years Experience Level.
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