Remote Pharmacovigilance Trial Consultant

Hydrogen Group; United States; Remote; USD 157,597,000 - 171,924,000; Full time

Job summary

Hydrogen Group is seeking a Clinical Trial Consultant / Pharmacovigilance Specialist for a remote (EST preferred) 12-month contract. The role focuses on end-to-end ICSR processing, safety case QC, and regulatory reporting to support global pharmacovigilance activities.

You will manage case triage, data entry, MedDRA coding, and follow-up queries while ensuring compliance with FDA, ICH, EU regulations, and internal procedures.

Qualifications

• Bachelor's degree in a science, healthcare, or related field.
• Minimum of 4 years of experience in pharmacovigilance.
• Demonstrated experience in ICSR processing and quality control.
• Experience with safety database systems such as ArisG, Argus, or Veeva.
• Working knowledge of global safety reporting regulations and pharmacovigilance guidelines.
• Experience with clinical trial safety cases and postmarketing case processing preferred.
• Experience with case reconciliation, retrospective quality checks, and investigation of late regulatory reporting preferred.

Responsibilities

• Managing the triage, intake, case entry, and QC of ICSRs from sponsored clinical studies or other assigned cases.
• Preparing case narratives, performing MedDRA coding, drafting follow-up queries, and communicating event notifications to internal stakeholders.
• Conducting retrospective quality checks on processed cases to ensure accuracy, completeness, and compliance.
• Independently managing assigned cases to meet internal deadlines and support timely regulatory reporting, including coverage for weekends and holidays.
• Reviewing and resolving reconciliation discrepancies between clinical and safety databases in collaboration with Data Management.
• Providing investigation details and supporting documentation for late regulatory reporting of clinical trial cases.
• Perform end-to-end ICSR processing, including case triage, intake, data entry, and quality review.
• Ensure case documentation, narratives, and medical coding meet established quality standards and regulatory requirements.
• Draft appropriate follow-up queries to obtain missing or additional safety information.
• Prepare and distribute event notifications to relevant internal stakeholders.
• Conduct retrospective QC reviews to identify errors, discrepancies, and opportunities for process improvement.
• Monitor case timelines and independently prioritize workloads to ensure timely case completion and regulatory submission.
• Coordinate with Data Management to investigate and resolve discrepancies between clinical trial and safety databases.
• Investigate and document the root causes and relevant details associated with late regulatory reporting of clinical trial cases.
• Maintain compliance with applicable global and local pharmacovigilance regulations, guidelines, and company procedures.
• Ensure accurate and complete safety case documentation to support audit readiness and regulatory compliance.

Skills

Global pharmacovigilance

FDA/ICH/EU regulations

ICSR processing

Narrative writing

Data discrepancy resolution

Attention to detail

Regulatory reporting deadlines

Cross-functional collaboration

Education

Bachelor's degree in science/healthcare

Tools

ArisG

Argus

Veeva

Job description

Hydrogen Group is seeking a Clinical Trial Consultant / Pharmacovigilance Specialist for a remote (EST preferred) 12-month contract. The role focuses on end-to-end ICSR processing, safety case QC, and regulatory reporting to support global pharmacovigilance activities.

You will manage case triage, data entry, MedDRA coding, and follow-up queries while ensuring compliance with FDA, ICH, EU regulations, and internal procedures.