Manager, PV Quality Issue Management [T500-17973]

Job Description

Position Summary: Provide management for the Patient Safety support for outcomes of internal audits of Pharmacovigilance (GVP) systems/processes, business partner audits of GVP processes, GVP deviation investigations and PV Quality Management System (QMS) support. Duties/ Responsibilities : Manage outcomes of GVP audits in terms of post-evaluation to ensure that corrective and preventative actions are authored and implemented in a timely manner. Support post-evaluation response to the GVP elements of GCP, GMP and GDP audits to ensure that corrective and preventative actions are authored and implemented in a timely manner for items impacting the GVP system. Effectively collaborate with external quality and compliance organizations (i.e. R&D Quality Assurance) to maintain high standards of quality for the department. Participate and or lead the individual assessments for the identification, risk assessment, investigation, and closure of GVP deviations for issues impacting the GVP system. Additionally, contribute to the suggested remediation efforts. Monitor CAPA, Effectiveness Check, Deviation and associated risk triggers for reporting to PV Quality Council and associated functional management. Define appropriate escalation process to ensure overall performance of the program. Manage the trending and analysis of quality issues from various sources for items impacting compliance and quality. Concisely summarizes and effectively communicates the result of analysis and intelligence with stakeholders as appropriate to address issues and prevent recurrence of quality and compliance issues. Suggest improvements to the review of departmental standard operating procedures related to CAPA management, effectiveness checks, deviation management and GVP QMS. Represent the PV Compliance and Quality Risk Management team partnering with other internal Research & Development/BMS stakeholders to align to principles of GVP QMS as it relates to CAPA management, effectiveness checks and deviation management. Ensure all data supporting deviations and open CAPA within the Pharmacovigilance System Masterfile (PSMF) is current and of high quality to enable applicable sections to be generated in a timely manner. Escalates issues to respective functions and management for evaluation and remediation. Show more Show less