Remote Pharmacovigilance Consultant II (ICSR)

GForce Life Sciences; Illinois; Remote; USD 90,000 - 120,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

ICSR processing

Regulatory knowledge

Communication

ArisG/Argus/Veeva

Microsoft Office

Medical terminology

Education

Bachelor's degree in science or healthcare

Tools

ArisG

Argus

Veeva

Job description

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.