Drug Safety

Integrated Resources, IncHorsham, PA

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Overview

Remote

On-site

Job Description

Drug SafetyA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionCase Processing: 75% of time Definition: The completion of full case information on the database, culminating in Quality Review to ensure accuracy and completeness. Activities Include:Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist)Confirmation of Safety Coordinator case registry data

Database searches as necessary

Completion of literature searches as necessary

Completion of remaining case data entry, including narrative or auto-narrativeCompletion of risk and quality (label, approval, manual coding & quality review steps)Clarification of unclear or illegible information from the LSO or Call CentreDiscuss source documents, coding conventions and ad-hoc queries with Medical Assessment PhysicianCompletion of protocol request forms as necessary

Preparation of deviation memo as necessary

Request deletions as necessary

Single case unblinding

Processes and Procedures: 5% of time Definition: Continuing awareness of company procedures and guidelines to maintain regulatory compliance. Activities Include:Standard Operating Procedures and Working PracticesDepartment guidance documents

MedDRA coding dictionary and MedDRA points to consider

Understand relevant safety implications regarding contracts with operating companies and/or marketing partners

Review and make suggestions for system and procedure enhancements5% of time = Project Work, Audits, Inspections and other Ad-hoc

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This job at Integrated Resources, Inc is located in Horsham, PA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

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