Clinical/Regulatory - Safety Data Coordinator

About The Role

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