Remote Clinical Trial ICSR & Pharmacovigilance Consultant

Hydrogen Group; Massachusetts; Remote; USD 76,000 - 83,000; Full time

Job summary

Hydrogen Group is seeking a Clinical Trial Consultant / Pharmacovigilance Specialist for a remote EST-preferred role. The 12-month contract involves end-to-end ICSR processing, quality control, and ensuring regulatory-compliant safety reporting.

You will collaborate with Data Management and internal safety stakeholders, covering weekends as needed. The role requires a bachelor’s in science or healthcare and at least 4 years in pharmacovigilance, with experience in ArisG, Argus, or Veeva.

Qualifications

• Bachelor's degree in science, healthcare, or related field.
• Minimum of 4 years of experience in pharmacovigilance.
• Experience with safety database systems such as ArisG, Argus, or Veeva.
• Working knowledge of global safety reporting regulations and pharmacovigilance guidelines.

Responsibilities

• Perform end-to-end ICSR processing, including case triage, intake, data entry, and quality review.
• Ensure case documentation, narratives, and medical coding meet standards and regulatory requirements.
• Draft follow-up queries to obtain missing safety information.
• Prepare and distribute event notifications to stakeholders.
• Conduct retrospective QC reviews to identify errors and process improvements.
• Monitor case timelines and prioritize workloads to meet deadlines for regulatory submission.
• Coordinate with Data Management to investigate discrepancies between databases.
• Investigate root causes and details of late regulatory reporting.
• Maintain compliance with global pharmacovigilance regulations and company procedures.
• Ensure complete safety case documentation for audit readiness.

Skills

Pharmacovigilance regulations

ICSR processing

Safety reporting

Medical terminology

Attention to detail

Time management

Communication skills

Microsoft Office

Team collaboration

Education

Bachelor's degree in science/healthcare

4+ years pharmacovigilance experience

Tools

ArisG

Argus

Veeva

Job description

Hydrogen Group is seeking a Clinical Trial Consultant / Pharmacovigilance Specialist for a remote EST-preferred role. The 12-month contract involves end-to-end ICSR processing, quality control, and ensuring regulatory-compliant safety reporting.

You will collaborate with Data Management and internal safety stakeholders, covering weekends as needed. The role requires a bachelor’s in science or healthcare and at least 4 years in pharmacovigilance, with experience in ArisG, Argus, or Veeva.