Remote Pharmacovigilance ICSR Consultant II

Tailored Management; United States; Remoto; USD 76.000 - 83.000; Tempo pieno

Vantaggi offerti da questo lavoro

Weekly pay

Medical Insurance

Dental Insurance

Vision Insurance

Descrizione del lavoro

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.

Competenze

• 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).

Mansioni

• 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.

Conoscenze

Pharmacovigilance

I CSR processing

Medical terminology

Communication skills

Formazione

Bachelor's degree in Science/Healthcare

Strumenti

Argus

ArisG

Veeva

Descrizione del lavoro

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.