Description: Our client is seeking a PV Quality Assurance consultant with 7-10 years of experience to support and enhance quality oversight within the PV function. This role is critical in ensuring compliance across processes, systems, affiliates, and vendor audits. While also supporting inspection management and fostering collaboration across Quality and PV teams. The ideal candidate will have a strong Quality Assurance (QA) background with expertise in deviations, CAPAs, and root cause analysis. The candidate must have experience from a high level of quality oversight from a QA perspective rather than just PV operations.
Key Responsibilities:
Drive Quality oversight by developing, implementing, and improving PV-related quality processes and systems.
Lead and execute PV audits across internal processes, systems, affiliates, and vendors.
Support inspection management activities, working cross-functionally with various Quality teams to ensure readiness.
Conduct deviation investigations, CAPA management, and root cause analyses to drive continuous improvement.
Ensure compliance with Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and other relevant regulatory requirements.
Collaborate with cross-functional teams to ensure alignment with Veeva, the company’s quality management system.
Work closely with external and internal stakeholders to establish best-in-class quality processes for PV.
Preferred Qualifications:
7-10 years of experience in PV Quality Assurance.
Strong understanding of GVP, GCP, and regulatory expectations related to PV.
Experience with PASS (non-interventional study) / Good Pharmacoepidemiology Practices (GPP) is highly desirable.
Experience in a large pharmaceutical company is strongly preferred, as this role involves building out and improving quality processes.