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Drug Safety Specialist II

  • Location: Bridgewater
  • Salary: 25.00-29.00
  • Contract hours: ZeroHour

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About the job

Responsible for the collection, data entry, routing, follow-up, and
timely reporting/submission of safety information (including expedited
and aggregate reports) related to drug products from a variety of
sources (clinical trial, spontaneous, literature), both US and
foreign, in compliance with SOPs, US regulations, and international
regulations. This position is especially important in light of the
approval and marketing of products and the number and diversity of
clinical trials. The FDA conducts periodic, detailed audits to ensure
integrity of AE processing, thoroughness of documentation, accuracy of
results, and timeliness of reports. This position is also responsible
for self-initiated quality review within each distinct process step.

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