Strategic PV Quality Director, Remote

BioSpace; Kansas; Hybride; USD 180 000 - 230 000; Plein temps

Résumé du poste

Civica, Inc. is seeking an experienced QA Associate Director, Pharmacovigilance to lead the pharmacovigilance program, manage case intake and regulatory reporting, and ensure GXP compliance across the product portfolio.

The role oversees third-party centers and PV vendors, with a strong emphasis on continuous improvement and inspection readiness. The position requires a minimum of ten years in pharmacovigilance or related fields, and the ability to lead complex projects with minimal supervision

Qualifications

• Minimum 10 years in pharmacovigilance, QA or related field.
• Experience establishing PV programs as MAH is a plus.
• Experience managing PV quality systems incl. deviations, CAPA, and change controls.
• Knowledge of US FDA and international regulations (GXP).

Responsabilités

• Lead Civica pharmacovigilance program and case intake.
• Oversee third party PV call center operations.
• Ensure regulatory reporting and submissions.
• Prepare for and host regulatory inspections.
• Manage vendor qualifications for PV vendors.
• Track metrics for leadership.

Connaissances

Quality systems

GXP compliance

Regulatory inspections

Project leadership

Communication skills

CAPA

Formation

Bachelor's degree in healthcare

Description du poste

Civica, Inc. is seeking an experienced QA Associate Director, Pharmacovigilance to lead the pharmacovigilance program, manage case intake and regulatory reporting, and ensure GXP compliance across the product portfolio.

The role oversees third-party centers and PV vendors, with a strong emphasis on continuous improvement and inspection readiness. The position requires a minimum of ten years in pharmacovigilance or related fields, and the ability to lead complex projects with minimal supervision