Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

Overview

In this role you will contribute to Medpace’s pharmacovigilance activities by coordinating safety reporting and QA tasks. You will work within a protocol-driven team to support regulatory submissions and cross-functional collaborations. You’ll handle safety report distribution, tracker upkeep, and communications with regulatory authorities, contributing to safe and effective therapeutics development. This position offers growth within a global safety organization and exposure to diverse therapeutic areas in a leading CRO.

Pay / Benefits

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Responsibilities

• Distribute safety reports to regulatory authorities
• Create and maintain project trackers and status reports
• Distribute and track safety-related notifications
• Conduct quality control reviews of departmental documents
• Interact with Clinical Operations, Data Management and Regulatory Submissions
• Perform other tasks as needed

Key requirements

• Degree level, Bachelor of Science
• 1+ years clinical trial safety experience
• Strong attention to detail
• Comprehensive understanding of Microsoft Office Suite
• GCP knowledge (preferred)
• EDC systems and clinical databases knowledge (preferred)
• Safety reporting guidelines knowledge (preferred)

• Collaborative team player
• Effective communicator across departments
• Attention to detail and thoroughness
• Microsoft Office Suite
• Electronic Data Capture (EDC) systems
• Clinical databases