Clinical Trial 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

CLINICAL TRIAL CONSULTANT / PHARMACOVIGILANCE SPECIALIST
LOCATION: Remote (EST preferred)
SCHEDULE: Standard EST hours, 40 hours per week
DURATION: 12-month contract
PAY: $55-60/hour

Job Responsibilities:

In this role, you will manage and support the processing and quality control (QC) of clinical trial Individual Case Safety Reports (ICSRs) and postmarketing safety cases originating from sanctioned countries. Key responsibilities include:

• 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.

Essential Duties and Job Functions:

• 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.

Knowledge & Skills:

• Strong knowledge of global and local pharmacovigilance regulations and safety reporting requirements.
• Understanding of FDA, ICH, and European Union pharmacovigilance regulations and guidelines.
• Hands-on experience processing ICsRS using safety database systems such as ArisG, Argus, and Veeva.
• Knowledge of clinical trial and postmarketing safety case processing requirements.
• Proficiency in medical terminology, clinical concepts, and medical practices.
• Strong written and verbal communication skills, including narrative writing and preparation of follow-up queries.
• Excellent attention to detail and the ability to identify and resolve data discrepancies.
• Strong organizational, analytical, and problem-solving skills.
• Ability to independently manage multiple cases and competing priorities in a deadline-driven environment.
• Ability to collaborate effectively with cross-functional teams, including Data Management and internal safety stakeholders.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Ability to manage case processing timelines while accounting for weekends, holidays, and regulatory reporting deadlines.

Education & Experience:

• 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.