US_Clinical Trial Consultant II

The confidential client is seeking a Clinical Trial Consultant II to support pharmacovigilance operations. The role processes and quality-checks clinical trial and post-marketing safety cases, ensuring accurate documentation and compliance with regulatory reporting timelines.

Tags

Consulting

Human Resources

Information Technology

Insider Connection @Tailored Management

2 email credits available today

Beyond your network

Karen Meaney (Girard) & 1 connections

From your previous company

& 2 connections

Previously@undefined and...

from your School

@undefined and...

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

Benefits

Weekly Pay

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)

Global staffing and recruitment services for employers and job seekers.

Columbus, Ohio, USA

http://tailoredmanagement.com

Late Stage

Leadership Team

Jeff Anderson

Managing Partner & Client Relations Executive

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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 least 4 years of professional experience in pharmacovigilance or drug safety operations.

Required skills

Pharmacovigilance Case Processing, Individual Case Safety Reports (ICSRs), Argus, ArisG, Veeva, MedDRA Coding, Medical Narrative Writing, FDA Safety Reporting, ICH Guidelines, EU Pharmacovigilance Regulations, Medical Terminology, Microsoft Office

Experience

4+ years