Clinical/Regulatory - Safety Data Coordinator

Futurewave Systems; Vernon Hills (IL); On-site; USD 24,796; Part time

Job summary

A leading HR service provider is seeking a Clinical/Regulatory - Safety Data Coordinator to ensure thorough monitoring of adverse events. The role involves data entry, writing narratives, and collaborating within global teams. Candidates should have a Bachelor's degree in sciences and excellent organizational and communication skills. Attention to detail and team orientation are crucial, along with familiarity with Safety Databases. This contract position offers a pay rate of $18 per hour.

Qualifications

• Excellence in document processing and ability to produce high-quality work.
• Strong organizational skills and attention to detail.
• Ability to multitask and prioritize effectively.

Responsibilities

• Register cases into the Global Safety Database and prevent duplicate entries.
• Perform data entry of adverse events and verify data against source documents.
• Write case narratives for non-serious cases.

Skills

Document processing excellence

Strong organizational skills

Excellent communication skills

Analytical problem-solving skills

Team collaboration

Customer service orientation

Education

Bachelor's degree in natural sciences or healthcare

Tools

Safety Databases

Spreadsheet software

Job description

Clinical/Regulatory - Safety Data Coordinator

We give companies of every size the tools to help their people thrive. From payroll, benefits and regulatory compliance to talent management and analytics, we help our clients succeed. As one of the world’s largest and most experienced HR providers, the company offers you recruit-to-retire services and solutions that help you build the team that will take you into the future. What we deliver isn’t just a better HR system; it’s a better workforce.

Title: Clinical/Regulatory - Safety Data Coordinator

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

• 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

Qualifications

• 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

Education and Experience

• 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