Drug Safety Associate
PAREXEL International - Durham, NC

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The Drug Safety Associate will provide technical and process-related support to drug safety
management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance
with relevant regulations and Standard Operating Procedures (SOPs).
Triage of incoming reports for completeness, legibility and validity
• Initial data entry of case reports into safety database / tracking system
• Assessment of case reports for seriousness, causality and expectedness
• Requesting follow-up i.e. written, telephone
• Adverse event (AE) and drug coding
• Writing case narratives
• Create and maintain project specific working files, case report files and project central files
• Assist with additional Drug Safety Specialist activities as required
• Inform Medical Project Managers and Regional Head of PV Operations of potential change-inscope
of projects
• Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities
such as:
o collection and review of endpoint packages
o review and follow-up laboratory alerts
o review and follow-up patient eligibility for inclusion / exclusion in clinical trials
o review and follow-up protocol violations
o review study specific Model ICFs according ICH/GCP criteria

PAREXEL International - 16 months ago - save job - block
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About this company
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PAREXEL International excels in pharmaceutical development services. A top contract research organization (CRO), the firm counts among its...