Job Details
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:
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