Clinical research associate vs pharmacovigilance safety expert

Differences between clinical research associate and pharmacovigilance safety expert duties and responsibilities

Clinical research associate example responsibilities.

• Manage, schedule and train up to 15 CRAs.
• Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
• Manage site TMF to ensure communication requirements adherence
• Manage CRO and regional monitor to complete close out activities, including device accountability management.
• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.
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Pharmacovigilance safety expert example responsibilities.

• Manage compliance issues, and provide feedback for risk assessments within safety/regulatory regulations for FDA reporting.
• Demonstrate and effectively used knowledge of FDA, ICH and GCP and safety reporting guidelines.
• Perform adequate duplicate search in database prior to book-in and creating cases in Argus.
• Develop and maintain training materials using PowerPoint presentations and computer-base training for new and current employees.
• Develop an ELISA biosensor system that detects toxins in food.