Pharmacovigilance Specialist

Piper Clinical Solutions  is seeking a  Clinical Research   Safety & Pharmacovigilance Specialist  in the  Bethesda, MD  area to support a well-established research organization that provides 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 :

Compensation for the Clinical Research   Safety & Pharmacovigilance Specialist :

This job opens for applications on 02 / 28 / 2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords :

Safety, pharmacovigilance, SAE, AE, serious adverse event, adverse event, CRO, Clinical research organization, clinical trials, pharmaceutical, biotechnology, biotech, gcp, good clinical practices, qms, quality management system, quality management plans, cqms, sop, standard operating procedures, protocol, quality assurance, qa, capa, investigations, audit, certified quality assurance auditor, CQA, clinical information, CIS, Clinical information specialist, Clinical Research Ethicist, HPS, human protection, clinical trial safety, human subject protection, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, infectious disease, IND, medical monitor, safety monitoring, monitor, medical research, EHR, electronic health record, safety narrative, food and drug administration, investigational new drug

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Salary : $65,000 - $85,000