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Clinical Research Safety & Pharmacovigilance Specialist

Job Attributes

Job Id:

30041

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

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

 

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, investigational new drug


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New Search

Job Id:

30041

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions