Remote Pharmacovigilance Consultant: ICSR & Safety Reporting

Tailored Management; Chicago (IL); Remote; USD 76.000 - 83.000; Vollzeit

Benefits dieser Stelle

Weekly Pay

Medical Insurance

Dental Insurance

Vision Insurance

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Pharmacovigilance

ICSR processing

Quality control

Medical terminology

Regulatory knowledge

Communication

Organizational skills

MS Office

Ausbildung

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

Tools

Argus

ArisG

Veeva

Jobbeschreibung

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.