US_Clinical Trial Consultant II

Tailored Management; Chicago (IL); À distance; USD 76 000 - 83 000; Plein temps

Avantages offerts par ce poste

Weekly Pay

Medical Insurance

Dental Insurance

Vision Insurance

Résumé du poste

Tailored Management seeks an experienced Clinical Trial Consultant II to support pharmacovigilance operations, focusing on ICSR processing and QC for clinical trials and post‑marketing sources. You will ensure accurate case documentation and timely regulatory reporting to meet deadlines.

The ideal candidate has hands-on pharmacovigilance case processing, safety databases (Argus/ArisG/Veeva), medical terminology knowledge, and global safety regulations. Remote work with EST preference.

Qualifications

• Bachelor’s degree in a life sciences or healthcare field.
• Minimum 4 years’ pharmacovigilance or drug safety experience.
• Hands-on ICSR processing for clinical trials or post‑marketing safety.
• Experience with pharmacovigilance safety databases (Argus, ArisG, or Veeva).
• Knowledge of MedDRA coding and safety reporting requirements (FDA/ICH/EU).
• Strong written/verbal communication and attention to detail.

Responsabilités

• Triage, intake, data entry, and quality control of ICSRs.
• Prepare and review medical narratives, MedDRA coding, and draft follow-up queries and event notifications.
• Conduct retrospective quality checks to ensure accuracy and compliance.
• Independently manage safety cases to meet deadlines and regulatory timelines.
• Investigate reconciliation discrepancies between clinical and safety databases.
• Provide investigation details and documentation for cases with delayed reporting.
• Ensure compliance with global/local regulations and internal standards.
• Maintain accurate case records and communicate updates to stakeholders.

Connaissances

Pharmacovigilance

ICSR processing

Quality control

Medical terminology

Regulatory knowledge

Communication

Organizational skills

MS Office

Formation

Bachelor's degree in Science / Life Sciences / Pharmacy / Nursing / healthcare-related field

Outils

Argus

ArisG

Veeva

Description du poste

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 IC…
• 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
• 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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