Intellectt Inc Columbus, OH

Medical Reviewer/Safety Reviewer - A

Intellectt Inc Columbus, OH

1 month ago 31 applicants

See who Intellectt Inc has hired for this role

Hello Everyone,

Greetings of the day.

This is Vydehi from Intellectt Inc. We currently have an opening for a Medical Reviewer/Safety Reviewer - A with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at +1 732 355 7412.

Role: Medical Reviewer/Safety Reviewer - A

Location: Columbus, OH

Duration: 12 Months

Shift Timings: 8 am to 5 pm

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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Employment type
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