Clinical Safety Specialist
22 hours ago
About the Role:
This Clinical Safety Specialist position is a key role at Medpace, playing a crucial part in the development of life-changing medicines. The successful candidate will be responsible for collecting, processing, and tracking serious adverse event reports, generating safety narratives and queries, and performing quality control of safety cases.
Responsibilities:
- Collect, process, and track serious adverse event (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 database and clinical database
- TMF uploads and quality control review
- Preparation of clinical safety documents as required (i.e., safety management plan, periodic safety reports and presentations)
- Attending internal and external meetings, as required (including sponsor TCs and audits/inspections)
- Leading clinical trial projects (ensure client deliverables are met, provide oversight and compliance reports)
Additional Responsibilities:
- Develop presentation material and present during face-to-face Sponsor meetings (i.e., Kick-off Meetings, Investigator Meetings)
- Coordinate final medical review of study report narratives and submission to Medical Writers
- Develop drafts of adjudication material (i.e., charter, reporting materials)
- Provide periodic safety summaries to project Data Manager, Clinical Trial Manager, and Medical Monitor
- Train new Clinical Safety Coordinators on safety reporting responsibilities
- Coordinate safety responsibilities for aggregate reporting purposes (e.g., ensure timely data entry, tracking of pending cases, collaborate with Medical Monitor and Regulatory Affairs)
What We Offer:
- Competitive salary: $80,000 - $110,000 per year
- Flexible work environment
- Competitive benefits package
- Structured career paths with opportunities for professional growth
- Employee health and wellness initiatives
- Recognition as one of America's Most Successful Midsize Companies by Forbes.
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