Job Description
Piper Companies (Health & Sciences) is seeking motivated candidates for a
Medical Monitor and/or
Safety & Pharmacovigilance Specialist opportunity in the
Montgomery County, 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 Medical Monitor: •Ensure compliance with Food and Drug Administration and World Health Organization regulations.
•Investigate, Manage and process all Serious Adverse Events (SAEs) for assigned clinical research trials
•Track and process assigned pharmaceutical and Data Management Center (DMC) queries
•Generate specified data reports from the safety database as requested
•Assist with the development of Investigator Brochures (IB) and provide direction to clients
•Process and edit safety narratives for Investigational New Drug (IND) and Non-IND Adverse Event (AE) cases as required
•Distribute Safety Information according to project specific requirements
•Maintain document control for safety & pharmacovigilance electronic files, perform file case searches & queries, maintain trial databases and ensure all files are up to date and accurate
•Utilize databases to track, manage and control issued documents and assign tracking numbers
•Assist in the preparation of contract-required reports
•Utilize MedDRA & WHODRUG codes for reporting
•Perform quality audits on AE reports
Requirements for the Medical Monitor: •3 + years of experience in clinical research and/or bioethics with preferred experience directly related to safety & pharmacovigilance
•Knowledge of regulations, policies and reporting relevant to the protection of human subjects in clinical trials: GCP, IRB, FDA, SAE reporting, IND applications
•Doctor of Medicine (MD) degree
Compensation for the Medical Monitor: •Salary Range: $100,000-$150,000 based on relevant experience
•Full Benefits: Health, Vision & Dental Insurance, 401K
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
Job Tags
Contract work,