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location: North Chicago, Illinois
job type: Contract
salary: $22.98 - 27.04 per hour
work hours: 9 to 5
- 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.
- Proficiency in Word, Excel, PowerPoint; ability to learn applications quickly; PV experience; Clinical Trials experience
- Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.
- 2 years clinical experience is required.
- Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.
- Sound understanding of product labeling/literature, including safety profile.
- Able to apply clinical knowledge to adverse event data collection and assessment.
- Competent in ability to present adverse event data, orally and in writing.
- Adheres to policies and regulations.
- Must be Computer proficient (Windows, Word, Excel).
skills: IND, CRF, FDA, Pharmacovigilance, MS-WORD, MS-EXCEL, MS-Powerpoint, SAE (Serious Adverse Event), ICH Regulations, AD (Adverse Events)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.