Full-time
US_Clinical Trial Consultant II
Competitive
Union, New Jersey, USAScience & PharmaceuticalPosted 21d ago
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Role overview
Job type
Salary
Competitive
Location
Sector
Posted
21 days ago
Job description
Responsibilities
Triage, Intake, case entry and QC of ICSRs originating from *** sponsored studies or other assigned cases
Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
Perform retrospective quality checks on processed cases
Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
Provide investigation details into late regulatory reporting of CT cases
Benefits
Remote work (Preferred EST)
Glassdoor
3.8
Enterprise staffing and workforce solutions.
Union, New Jersey, USA
http://www.mindlance.com
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Management and Executive
Engineering and Development
Sales
Customer Service and Support
Accounting and Finance
Marketing
Legal and Compliance
Creatives and Design
Trends of Total Sponsorships
*2026
(53)
2025
(71)
2024
2023
(37)
2022
(72)
2021
(36)
2020
(40)
Qualifications
Knowledge of Global and local safety regulations
Excellent written and verbal communication skills
Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
Bachelor's degree in science or healthcare related field
4+ years experience in pharmacovigilance
Required skills
ICSR Processing, Pharmacovigilance, ArisG, Argus, Veeva, Global and Local Safety Regulations, FDA Regulations, ICH Guidelines, EU Pharmacovigilance Regulations, Medical and Clinical Practices, Medical Terminology, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook
Experience
4+ years
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