Katalyst CRO ยท 1 month ago
Safety Information Specialist
Katalyst CRO is looking for a Safety Information Specialist to manage the registration of adverse events and product quality reports. The role involves quality reviews, effective communication, and delivering high customer service while identifying areas for improvement.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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 the ability to work collaboratively and effectively within a team
Fast learner of technical and process skills/knowledge
Effective verbal and written skills
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
Preferred
Medical terminology knowledge preferred
Prior experience in a regulatory/medical setting preferred
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageRecent News
2024-04-07
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