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Drug Safety

Integrated Resources, Inc

Horsham, Pennsylvania

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Clinical Research, Code Reviews, Data Entry, Establish Priorities, Information Technology & Information Systems, Maintain Compliance, Marketing, Medical Coding, Medical Dictionary for Regulatory Activities (MedDRA), Organizational Skills, Pharmacovigilance, Protocol Analysis, Query Analysis, Rehabilitation Nursing, Risk, Standard Operating Procedures (SOP)
LOCATION
Horsham, Pennsylvania
POSTED
2 days ago
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 dataDatabase searches as necessaryCompletion of literature searches as necessaryCompletion 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 necessaryPreparation of deviation memo as necessaryRequest deletions as necessarySingle case unblindingProcesses 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 documentsMedDRA coding dictionary and MedDRA points to considerUnderstand relevant safety implications regarding contracts with operating companies and/or marketing partnersReview and make suggestions for system and procedure enhancements5% of time = Project Work, Audits, Inspections and other Ad-hoc

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Integrated Resources, Inc

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