Clinical Trial Consultant

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.

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