Safety and Pharmacovigilance Specialist job vacancy

Vacancy expired!

Piper Clinical Solutions is seeking a

Safety & Pharmacovigilance Specialist in the

Bethesda, MD area to support a well-established CRO focused on providing thorough support to trials run by both commercial and federal entities.

Responsibilities for the Safety & Pharmacovigilance Specialist:

• Manage and process all SAEs as per project-specific instructions

• Document Control: maintain electronic files for the 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

• Utilize knowledge of the Data Management Center (DMC) to track and process queries

• Prepare reports based on off-contract requirements

• Provide summarized data reports from the safety database

• Use extensive writing and attention to detail skills to provide summaries of Serious Adverse Events (SAE) cases as required by protocol

• Lead in the implementation of Safety regulations for all trials

• Assist in the processing of MedDRA coding tasks

• Perform QC on AE submissions

Requirements for the Safety & Pharmacovigilance Specialist:

• 3+ years of experience in clinical research or the medical field

• Knowledge of regulations/policies relevant to the protection of human subjects in clinical trials

• Experience with IRB/GCP regulations

• PhD, MD/ECFMG, or PharmD in Science related field

Compensation for the Safety & Pharmacovigilance Specialist:

• Salary Range: $70,000 - $100,000 based on years of experience

• Full Benefits: Health, Vision & Dental Insurance, 401K

Vacancy expired!

ID	#49540837
State	Maryland
City	Bethesda
Job type	Permanent
Salary	USD TBD TBD
Source	Zachary Piper Solutions, LLC
Showed	2023-03-25
Date	2023-03-24
Deadline	2023-05-23
Category	Science/biotech
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Job Details

Safety and Pharmacovigilance Specialist