Job Listing
Clinical Trial and Pharmacovigilance Operations Manager
Defense Health Agency · Posted 54 days ago
Hybrid Fort Detrick, MD $122K – $187K Apply by May 22, 2026 General Health Science ISTJ EngineeringOperationsHealthcare
Apply for this job → About the Role
About the Position: MRDC is now part of the Defense Health Agency (DHA) Research & Development (R&D). We are the medical materiel developer, with responsibility for medical research, development and acquisition. Our expertise in these critical areas helps establish and maintain the capabilities the military needs to remain ready and lethal on the battlefield. Please visit our website https://mrdc.health.mil/ This is a Direct Hire Solicitation
What You'll Do
- →Manage all aspects of safety pharmacovigilance (PV) for Food and Drug Administration (FDA) regulated clinical trials and emergency use applications across various disease areas and research programs.
- →Perform sponsor’s assessment of adverse event reports for seriousness, expectedness and causality, determine Food and Drug Administration (FDA) reporting requirements for individual cases, maintain serious adverse event safety database.
- →Ensure studies are conducted in compliance with protocol, current Good Clinical Practices (cGCP), and relevant regulations and guidance.
- →Develop and review clinical research protocols, monitoring plans, safety plans, and associated documents.
- →Review investigational brochures, case report forms, and informed consent compliance.
- →Review submissions to the FDA for regulatory compliance and quality.
- →Serve as liaison between satellite trial sites and the Sponsor.
- →Educate other investigators regarding regulatory requirements.
- →Ensure PV and clinical operations activities comply with GCP, local regulations, and Standard Operating Procedures.
- →Prepare for and manage audits and inspections; implement Corrective and Preventative Actions (CAPAs) and track their effectiveness.
- →Develop and deliver training to internal teams and relevant vendors on safety reporting, GCP, and operational procedures.
Requirements
- ✓For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.
- ✓Some federal jobs allow you to substitute your education for the required experience in order to qualify.
- ✓For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted.
Personality Fit
This role is commonly a great fit for these MBTI types:
Job ID: 8c6beefa-be44-41b8-9964-39bd42882b7f
Posted via USAJobs