Clinical Safety Coordinator – Pharmacovigilance / Drug Safety

Overview

In this Clinical Safety role, you will support Medpace’s pharmacovigilance activities to ensure timely safety reporting for life-changing medicines. You work within a cross-functional Clinical Safety team to manage SAE processing, safety documents, and safety data reconciliation, contributing to compliant, high-quality trial safety. You will engage in sponsor meetings, audits, and project oversight to help deliver client deliverables and safety deliverables. This is an opportunity to grow in a fast‑moving PV environment at a global CRO with a clear mission to accelerate safe drug development.

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

• Collect, process, and track SAE reports
• Generate safety narratives and queries
• Safety database data entry
• Perform quality control of safety cases
• Generate Investigator Safety Letters
• SAE reconciliation between safety and clinical databases
• TMF uploads and quality control review
• Prepare clinical safety documents (safety management plan, periodic safety reports, presentations)
• Attend internal and external meetings (sponsor TCs, audits/inspections)
• Lead clinical trial projects (ensure client deliverables, provide oversight and compliance reports)
• Develop presentation material for Sponsor meetings
• Coordinate final medical review of study report narratives and submission
• Develop drafts of adjudication material (charter, reporting materials)
• Provide periodic safety summaries to project Data Manager, CTM, and Medical Monitor
• Train new Clinical Safety Coordinators on safety reporting responsibilities
• Coordinate safety for aggregate reporting (timely data entry, pending cases tracking)

Key requirements

• Bachelor’s degree in life sciences
• 2+ years of Clinical Trial Pharmacovigilance experience
• Working knowledge of Safety Databases (Argus desirable)
• Advanced knowledge of medical terminology, global safety reporting requirements and GCP
• Exposure to global trials as part of a multidisciplinary team

• Argus (Safety Database)
• medical terminology
• global safety reporting requirements
• Good Clinical Practice (GCP)

…