US_Clinical Trial Consultant II

Clinical Trial Consultant II

Location: Cambridge, MA - Hybrid (2 days onsite)/open 100% remote

Duration: 1+ Year

Number of Hours per week: 40 per week

Job Scope

Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries.

Key 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 collaboration with Data Management
• Provide investigation details into late regulatory reporting of CT cases

Essential Skills and Qualifications Required

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 and Experience Requirements for Job

Education: Bachelor's degree in science or healthcare related field

Experience: 4+ years experience in pharmacovigilance

Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.