Clinical/Regulatory - Safety Data Coordinator

Title: Clinical/Regulatory - Safety Data Coordinator

Location: 440 N Fairway Vernon Hills IL USA 6006

Pay Rate: $18 per hour

Term: Contract

This position is a member of the Safety Operations functional area within Global Drug Safety located in Vernon Hills, Illinois. 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. The position also requires the review of other non-case emails and forwarding them to the correct individual/team for action. Duties include case intake and case creation and data entry of adverse event related information, including but not limited to duplicate checks within the Global Safety Database, narrative writing and coding using the MedDRA Coding Dictionary.
Responsibilities include, but are not limited to the following:
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
Writing of case narratives for non-serious cases
Assist with the coding of adverse events, drug indications, lab tests, medical history terms and cause of death as appropriate per case
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
Provide input and assistance for process improvement opportunities
Interface with other departments and functional areas in regards to data clarification and reconciliation
Take initiative to recognize, prioritize and escalate potential safety/ compliance issues
Assist with training other staff as necessary
Participate on project teams and committees as assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Excellence in document processing and ability to consistently produce high quality work
Strong organizational skills and attention to detail
Ability to multitask and prioritize
Excellent written and oral communication skills
Capacity to analyze and resolve problems with analytical and problem solving skills
Ability to work under strict deadlines and changing priorities with minimal supervision
Operates effectively in a team environment
Technical system skills (e.g. word processing, spreadsheet and Safety Databases)
Strong customer service orientation
Knowledge of ICH guidelines and other worldwide reporting regulations preferred
Knowledge of medical terminology
Include the education and experience that is necessary to perform the job satisfactorily.
Bachelor's degree required, preferably in natural sciences or health care related profession.
Related experience in medical documentation, Pharmacovigilance, Regulatory Affairs, clinical research, quality assurance, medical support or preferred

Requirements:
Minimum 1-2 years office experience
Previous experience in medical/clinical data processing preferred

Andy Bundad | Recruiter | Futurewave Systems, Inc.

Mobile: 6782719241

https://www.linkedin.com/in/dyan-bundad-3a439610b?trk=nav_responsive_tab_profile

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