Clinical Research Safety & Pharmacovigilance Specialist

Piper Companies - Bethesda, MD4.3

Full-time$60,000 - $85,000 a year
EducationSkillsBenefits
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

Requirements for the Clinical Research Safety & Pharmacovigilance Specialist:

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, or PharmD in Science related field

Compensation for the Clinical Research Safety & Pharmacovigilance Specialist:

Salary Range: $60,000-$85,000 based on relevant experience
Full Benefits: Health, Vision & Dental Insurance, 401K

Please send all qualified resumes to: bnoell@pipercompanies.com