Drug Safety Coordinator

The Fountain Group is currently seeking a  Drug Safety Coordinator  for a prominent client of ours. This position is located in Clayton, NC .  Details for the position are as follows:


Job Title: Drug Safety Coordinator
Location: [Location Not Provided]
Pay Rate: $19.23–$26.00/hr
Duration: 1 Year

• Support Global Drug Safety/Pharmacovigilance activities with minimal oversight.
• Review incoming source documents to identify potential adverse event (AE) information.
• Track, document, and file AE reports and supporting documentation.
• Determine whether reports are initial, follow-up, or duplicate cases and create case folders.
• Assess the completeness of AE reports and identify the need for reporter follow-up.
• Maintain tracking logs and provide reports to the appropriate case owner.
• Review and manage literature sources that may contain AE information.
• Remove confidential patient information from source documents in accordance with applicable requirements.
• Record protocol and site/patient information on applicable source documents.
• Support adherence to GCP, regulatory reporting requirements, and company SOPs.
• Maintain an understanding of clinical study protocols and scope of work.

Education

• Associate degree required.
• 2–3 years of recent clinical setting experience or equivalent combination of experience and training.

Required Skills

• Adverse Event (AE) identification and documentation.
• Clinical safety or pharmacovigilance processes.
• Medical terminology.
• Clinical study documentation and source document review.
• GCP requirements and regulatory reporting practices.
• AE report tracking, case identification, and duplicate assessment.
• Clinical protocol and site/patient documentation.
• Pharmacovigilance literature review.
• Strong computer proficiency.

Preferred Skills

• ARGUS or other drug safety/safety database experience.
• Clinical drug development experience.
• Global Drug Safety/Pharmacovigilance experience.
• Experience processing and reviewing adverse event reports.