Clinical Trial Consultant II

GForce Life Sciences; Illinois; À distance; USD 90 000 - 120 000; Plein temps

Résumé du poste

GForce Life Sciences seeks a Senior Safety Associate (Clinical Trial Consultant) for a 6-month remote contract supporting EST hours. You will handle case processing and QC of ICERs from sanctioned countries and assist postmarket case processing.

Responsibilities include narrative writing, MedDRA coding, and drafting follow-ups for internal stakeholders, with focus on timely regulatory reporting and data integrity.

Qualifications

• Bachelor’s degree in science or healthcare related field required.
• 4+ years of experience in pharmacovigilance.
• Strong knowledge of FDA/ICH/EU pharmacovigilance regulations.
• Excellent written and verbal communication skills.
• Proficient in MS Word, Excel, PowerPoint, Outlook.

Responsabilités

• Triage, Intake, case entry and QC of ICERs from studies or assigned cases.
• Narrative writing, MedDRA coding, drafting follow-up queries and event notifications.
• Perform retrospective quality checks on processed cases.
• Independently manage assigned cases, including weekends/holidays, to ensure timely delivery for regulatory reporting.
• Review and resolve reconciliation issues between clinical and safety databases with Data Management.
• Provide investigation details into late regulatory reporting of CT cases.

Connaissances

ICSR processing

Regulatory knowledge

Communication

ArisG/Argus/Veeva

Microsoft Office

Medical terminology

Formation

Bachelor's degree in science or healthcare

Outils

ArisG

Argus

Veeva

Description du poste

Senior Safety Associate (Clinical Trial Consultant)

6 month contract

Must be able to work on a W2

Remote, EST hours

Job Scope:

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

Key Responsibilities

• Triage, Intake, case entry and QC of ICERs originating from organization 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

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