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
• Data mining/extrapolation, source data examination and cleaning
• Assessment of case reports for seriousness, causality and expectedness
• Adverse event (AE) and drug coding
• Requesting follow-up i.e. written, telephone
• Perform query resolution and initiate direct contact/follow-up with sites for additional information
• Create and maintain project specific working files, case report files and project central files
• Writing case narratives; medical and technical writing for clinical study reports and annual reports
• Inform Medical Project Managers and Regional Head of PV Operations of potential change-in scope of projects
• Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities
• Assist with additional Drug Safety activities as required
• Introduction to GCP
• FDA and Institutional Review Board (IRB)/Independent Ethics Committee (IRB/IEC)
• Investigator Role/Responsibilities
• Sponsor’s Responsibilities
• Monitor’s Responsibilities
• Safety & Adverse Event Reporting
• Clinical Trial Protocol and Amendments
• Investigator Brochure
• Essential Documents
• Additional Draft FDA Guidelines
• Other Useful Documents
Employers interested in Clinical Data Manager Apprenticeships should contact us using the form down below.
If you are interested in starting your career in one of our Clinical Data Manager Apprenticeships then submit your resume on our page for Prospective Apprentices.
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