Clinical Trial Consultant (Pharmacovigilance)

Tailored Management; United States; Remote; USD 76,000 - 83,000; Full time

Benefits offered by this job

Weekly pay

Medical Insurance

Dental Insurance

Vision Insurance

Job summary

Tailored Management is seeking an experienced Clinical Trial Consultant II to support pharmacovigilance operations. The role focuses on processing and QC of ICSRs from trials and post-marketing sources, ensuring accurate documentation and timely regulatory reporting.

The candidate should have hands-on pharmacovigilance case processing experience, knowledge of MedDRA coding, and familiarity with safety databases like Argus, ArisG, or Veeva.

Qualifications

• Bachelor's degree in Science, Life Sciences, Pharmacy, Nursing, or healthcare field.
• At least 4 years of professional pharmacovigilance or drug safety experience.
• Hands-on experience processing ICSRs for clinical trials and post-marketing safety cases.
• Experience using pharmacovigilance databases such as Argus, ArisG, or Veeva.
• Knowledge of MedDRA coding, case intake/triage, and quality control.
• Understanding of FDA, ICH, EU pharmacovigilance regulations.
• Strong written and verbal communication, attention to detail, and organization.
• Proficiency with MS Office (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Perform triage, intake, data entry, and quality control of ICSRs from trials and post-marketing.
• Prepare and review medical narratives, perform MedDRA coding, and draft follow-up queries.
• Conduct retrospective quality checks to ensure accuracy and compliance.
• Independently manage safety cases to meet deadlines and regulatory timelines.
• Investigate and resolve reconciliation discrepancies between safety and data management systems.
• Provide investigation details and supporting documentation for delayed reporting cases.
• Ensure compliance with global/local pharmacovigilance regulations and internal quality standards.
• Maintain accurate case records and communicate updates to stakeholders.

Skills

Pharmacovigilance

I CSR processing

Medical terminology

Communication skills

Education

Bachelor's degree in Science/Healthcare

Tools

Argus

ArisG

Veeva

Job description

Clinical Trial Consultant II – Pharmacovigilance

Work Arrangement: Remote - US Only ( EST Preferred)

Pay Rate: $55.00–$60.23 per hour on W2

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 I C SRs 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.

At Tailored Management, we help people get jobs and take pride in their work, so we better take pride in ours too. Not every company has the opportunity to meaningfully and directly impact individuals in a way that makes their lives tangibly better. To better support our employees, we offer a wide variety of benefit options to support you. We offer:

• Medical Coverage – HDHP, PPO, and Surest plan options