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Clinical Research Regulatory Affairs Associate

Job Attributes

Job Id:

30048

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 Human Safety & Pharmacovigilance Associate 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 Human Safety & Pharmacovigilance Associate:

·       Manage and process all SAEs (Serious Adverse Event) as per project specific instructions

·       Generate data reports based on research project needs

·       Query data from clinical research databases

·       Analyze and process safety reports and notifications of SAE/AE’s

·       Review narratives related to SAE’s and IND’s

·       Manage electronic files for the Safety & Pharmacovigilance Department

 

Requirements for the Human Safety & Pharmacovigilance Associate:

·       1+ years of experience in bioethics or a clinical research environment

·       Knowledge of medical terminology

·       Bachelor’s Degree in Science related field


Compensation for the Human Safety & Pharmacovigilance Associate: 

·       Salary Range: $40,000-$55,000 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:

30048

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions