IR
Clinical Trial Consultant II/ Sr. Safety Associate- Remote
Integrated Resources, Inc
- 🇺🇸 United States
- Remote
- Senior
- 1 day ago
- triage
- Argus
- Veeva
- ICH
- Excel
- PowerPoint
- Outlook
1 day ago
Duration: 12 Months+ Possible Extension
Location: Cambridge, MA/Â Remote (Preferred EST)
Pay Range: $55-$60/hr
Job Product:
Responsible for case processing and/or QC of clinical trial ICSRs and post-market case processing from sanctioned countries.
Key Responsibilities:
- Triage, Intake, case entry and QC of ICSRs originating from client 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
- 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
- Education : Bachelor’s degree in science or healthcare related field
- Experience : 4+ years experience in pharmacovigilance
Clinical Trial Consultant II/ Sr. Safety Associate- Remote · Integrated Resources, Inc