Vacancy expired!
Piper Clinical Solutions is seeking a Clinical Research Safety & Pharmacovigilance Specialist in the Bethesda, MD area to support a well-established research organization focused on providing biopharmaceutical development support, health information services, and health & environment assessments for commercial and government clients.
Responsibilities for the Clinical Research Safety & Pharmacovigilance Specialist:- Manage and process all SAEs as per project specific instructions
- Document Control: maintain electronic files for department, perform file case searches, maintain file room for the department and use department databases to track, manage and control issued documents; assign various tracking numbers
- Track and process assigned pharmaceutical and Data Management Center (DMC) queries
- Assist in the preparation of contract-required reports
- Generate specified data reports from the safety database as requested
- Process and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as required
- Distribute Safety Information according to project specific requirements
- Assist in processing of MedDRA coding tasks
- Perform QC on AE submissions
- 1-3 years' of experience in bioethics or a clinical research environment
- Knowledge of regulations/policies relevant to the protection of human subjects in clinical trials
- Experience with IRB/GCP regulations
- PhD, MD, ECFMG or PharmD in Science related field
- Salary Range: $65,000-$85,000 based on years of relevant experience
- Full Benefits: Health, Vision & Dental Insurance, 401K
Vacancy expired!