Safety Information Specialist: Data Integrity & Compliance

Katalyst CRO; North Chicago (IL); On-site; USD 42,000 - 65,000; Full time

Job summary

Katalyst CRO is seeking a detail-oriented regulatory/medical administrative specialist to support adverse event and product quality reporting workflows. The role emphasizes timely data entry, quality review, and clear communication with customers and internal teams.

Responsibilities include filing and reviewing case data, maintaining timelines, and collaborating with cross-functional groups to improve processes. Strong computer skills and medical terminology knowledge are beneficial.

Qualifications

• 6 months to 1 year of similar work experience.
• Excellent computer and keyboarding skills including Excel, PowerPoint, Word and Outlook.
• Prior experience and familiarity with computer databases.
• Superior attention to detail, quality, accuracy and timelines.
• Strong time management and prioritization skills; ability to multi-task.
• Strong adaptability to switching tasks to meet business needs.
• Strong customer service skills.
• Ability to work independently with minimal supervision as well the ability to work collaboratively and effectively within a team.
• Fast learner of technical and process skills/knowledge.
• Effective verbal and written skills.
• Medical terminology knowledge preferred.
• Prior experience in a regulatory/medical setting preferred.
• 3 to 5 years of experience or application/environment specific knowledge to perform tasks where large quantities of information, data or documents need to be maintained or manipulated in a structured database, filing system or associated reporting/holding format.

Responsibilities

• Accurate and timely registration of adverse event and product quality report from initial receipt to data entry within required timeframes.
• Performing Quality Review of external provider's reconciliation tasks for Clinical and Post-marketing (Medical Information, Product Complaints and third-party vendor ) cases.
• Clearly and succinctly communicates information to customers verbally and in writing.
• Demonstrates a high level of customer service to both internal and external customers.
• Utilizes judgment skills to identify issues that impact the workflow.
• Uses rigorous logic and methods to solve difficult problems with effective solutions.
• Identifies gaps and areas that need improvement and communicates and/or implements recommendations/changes.
• Performing tasks outside one's own area of responsibility to help with departmental needs
• Effectively prioritizes and manages own time to complete assigned tasks.

Skills

Attention to detail

Time management

Multitasking

Customer service

Communication skills

Teamwork

Regulatory knowledge

Tools

Excel

PowerPoint

Word

Outlook

Databases

Job description

Katalyst CRO is seeking a detail-oriented regulatory/medical administrative specialist to support adverse event and product quality reporting workflows. The role emphasizes timely data entry, quality review, and clear communication with customers and internal teams.

Responsibilities include filing and reviewing case data, maintaining timelines, and collaborating with cross-functional groups to improve processes. Strong computer skills and medical terminology knowledge are beneficial.