Safety Information Specialist

Join to apply for the Safety Information Specialist role at Katalyst CRO
.

• Accurate and timely registration of adverse event and product quality report from initial receipt to data entry within required time frames.
• Perform 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 communicate information to customers verbally and in writing.
• Demonstrate a high level of customer service to both internal and external customers.
• Utilize judgment skills to identify issues that impact the workflow.
• Use rigorous logic and methods to solve difficult problems with effective solutions.
• Identify gaps and areas that need improvement, and communicate/implement recommendations/changes.
• Perform tasks outside one's own area of responsibility to help with departmental needs.
• Effectively prioritize and manage own time to complete assigned tasks.

• 6 months to 1 year of similar work experience.
• Excellent computer and keyboarding skills including Excel, PowerPoint, Word and Outlook (or equivalent email system).
• 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 as 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.
• Candidates must possess 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.

Associate

Contract

Information Technology

Pharmaceutical Manufacturing