US_Clinical Trial Consultant II

Clinical Trial Consultant II – Pharmacovigilance
Work Arrangement: Remote (EST preferred)
Pay Rate: $55.00–$60.23 per hour
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance

Position Overview

We are seeking an experienced Clinical Trial Consultant II to support pharmacovigilance operations, focusing on the processing and quality control (QC) of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources. This role is responsible for ensuring accurate case documentation, compliance with applicable safety reporting regulations, and timely case completion to support regulatory reporting deadlines.

The ideal candidate has hands-on experience with pharmacovigilance case processing, safety database systems, medical terminology, and global drug safety regulations.

Key Responsibilities:

• Perform triage, intake, data entry, and quality control of clinical trial ICSRs and assigned post-marketing safety cases.
• Prepare and review medical narratives, perform MedDRA coding, and draft follow-up queries and event notifications for internal stakeholders.
• Conduct retrospective quality checks on processed cases to ensure accuracy, completeness, and compliance with established procedures.
• Independently manage assigned safety cases to meet internal deadlines and applicable regulatory reporting timelines, including coverage requirements for weekends and holidays.
• Investigate and resolve reconciliation discrepancies between clinical and safety databases in collaboration with Data Management.
• Provide investigation details and supporting documentation for cases involving delayed regulatory reporting.
• Ensure case processing activities comply with applicable global and local pharmacovigilance regulations and internal quality standards.
• Maintain accurate case records and communicate case-related issues, discrepancies, and processing updates to relevant stakeholders.

Qualifications:

• Bachelor’s degree in Science, Life Sciences, Pharmacy, Nursing, or a healthcare-related field.
• At least 4 years of professional experience in pharmacovigilance or drug safety operations.
• Hands-on experience processing Individual Case Safety Reports (ICSRs) for clinical trials and/or post-marketing safety cases.
• Experience using pharmacovigilance safety databases such as Argus, ArisG, or Veeva.
• Knowledge of medical narrative writing, MedDRA coding, case intake, triage, and quality control.
• Understanding of global and local safety reporting requirements, including FDA, ICH, and EU pharmacovigilance regulations.
• Knowledge of medical and clinical practices, terminology, and concepts.
• Strong written and verbal communication skills, attention to detail, and organizational abilities.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Ability to independently prioritize case assignments, resolve discrepancies, and meet time-sensitive reporting deadlines.

• Medical Coverage– HDHP, PPO, and Surest plan options
• Minimum Essential Coverage (MEC)
• Dental Insurance
• Vision Insurance
• Short-Term Disability (STD)
• Long-Term Disability (LTD)
• Life & AD&D Insurance
• Critical Illness Insurance
• Accident Insurance
• Employee Assistance Program (EAP)

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