Futurewavesystems

Clinical/Regulatory - Safety Data Coordinator

Vernon Hills, IL, United States

Sponsorship not specifiedDetected 3592 days ago

ComplianceProcess ImprovementCustomer SupportClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchCommunicationProblem SolvingOrganizational SkillsRegulatory Affairs

About the role

We give companies of every size the tools to help their people thrive.
The position also requires the review of other non-case emails and forwarding them to the correct individual/team for action.
Mobile: 6782719241 https://www.linkedin.com/in/dyan-bundad-3a439610b?trk=nav_responsive_tab_profile Futurewave Systems is #145 on Inc 500

Responsibilities

This position is responsible for the monitoring of the global adverse event email box which includes triage of incoming initial and follow up source documents for adverse event case reports.
Register cases into the Global Safety Database and perform systematic review of the Global Safety Database to ensure that duplicate case entry does not occur
Perform data entry of adverse events
Verify data against source documents and perform Quality Check of cases
Develop and maintain expert knowledge of the Global Safety Database
Collaborate with other Global Drug Safety (GDS) staff concerning adverse events and other safety-related issues
Support case report distribution
Perform database reconciliations
Excellence in document processing and ability to consistently produce high quality work

Requirements

Minimum 1-2 years office experience
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Benefits

Assist with the coding of adverse events, drug indications, lab tests, medical history terms and cause of death as appropriate per case

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