PV QA Manager

Summary / purpose of the position * To maintain, develop and monitor the pharmacovigilance (PV) quality management system to ensure its compliance with regulatory requirements and internal standards. * To act as primary point of contact for Global Patient Safety (GPS)/PV functions regarding the Global PV quality management system. * To support cross-functional processes impacting PV quality system, including but not limited to regulatory affairs, clinical and medical affairs, affiliates, business units etc. * To contribute to the promotion of a culture of continuous improvement Main responsibilities / job expectations * Deviations to Pharmacovigilance Processes 1. Audits and Inspections * Coordinate the preparation of external vigilance audits and inspections * Ensure hosting of external vigilance audits and inspections, ensure back office appropriate organization and ensure appropriate owner’s responses are delivered on time * Acts as primary contact for requests on PV Quality Management System * Coordinate post-audit/inspections activities 2. Sef-Identified deviations * Accountable for overall oversight and management of deviations related to or impacting the Ipsen PV system (review/approval process, tracking and reporting status) 3. CAPA Management * Coordinate the management of CAPA Plans from development to approval * Ensure CAPA tracking, monitoring, and reporting * Coordinate conduct of Effectiveness Checks * Quality Documents Management * Ensure the maintenance of PV Quality Documents System by supporting their creation and update as per quality documents life cycle management. * Guide authors/owners as Subject Matter Expert for safety and vigilance activities and quality * assurance * Oversee PV quality document schedule including: Coordination of QDs plans, coordination of the QDs review/approval process, tracking and reporting status * Change Control Coordinate implementation of change control process for main changes impacting the PV system from including corresponding CAPA management from review, approval, tracking, monitoring, reporting to effectiveness checks * PSMF Review * Support GPS/PV/Safety Functions on the review of the Global Pharmacovigilance System Master File (PSMF) and Local PSMF as applicable. * Ensure review and timely update of the annexes/sections related to QMS including quality documents, audits findings and CAPA updates as well as audit notes * Training * Develop and deliver training related to PV QMS * Ensure quality review of the yearly training program regarding Vigilance activities * Contribute to training compliance monitoring * Affiliate Support * Establish best practices among affiliates by supporting them with necessary guidance on PV QMS * Provide support to PV and/or QA local functions in conduct of compliance investigations regarding activities impacting the PV Sytem. * Monitor Local deviations to PV processes (self-identified deviations, or deviations raised via audits and inspections) for EUQPPV oversight and PSMF update * Key Performance Indicators (KPI) * Implement and tracks Quality KPIs * Provides quality updates for EU QPPV oversight and escalate main issues as appropriate * Ensures KPIs for PV system are in place and are tracked by the relevant functions and that relevant issues are reported to Quality system * Quality Objectives * Contribute to development of quality objectives related to PV QMS that are aligned with the Global Quality objectives. * Contribute to periodic reviews of PV QMS * Provides Advisory support for quality matters to PV staff and main interfaces * Support transversal quality projects (e.g. Quality Alert reporting, E2E Labelling etc) * Act as Subject Matter Expert (SME) for PV QMS topics * EHS Responsibilities * Comply with applicable EHS regulations and procedures. * Participate in the site's EHS performance by reporting risks, malfunctions or improvements * Participate in mandatory EHS training Knowledge, abilities & experience Education / Certifications: * Scientist/Pharmacist Experience: * 8 years of relevant experience in the field of pharmacovigilance system including 3 years in Pharmacovigilance quality management or PV Compliance management Abilities: * Cross-functional working skills * Good communication skills * Result oriented – drives execution and accountability * Demonstrates agility and flexibility Languages: * Fluent English Key Technical Competencies Required * Thorough knowledge and understanding of regulatory requirements and industry standards in GPvP * Experience in Pharmacovigilance * Experience in Quality Management System design and content * Experience with major Health authorities Pharmacovigilance inspections Other Useful Information * Key Internal stakeholders: Global and local PV Staff, Quality Assurance Groups and all business functions in interface with PV staff including but not limited to Regulatory Affairs/Medical Affairs/Clinical Operations etc. * Key External contacts: Heath Authorities, Commercial Partners * Financial budget: Global Regulatory Quality * Number of direct reports: 0 The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.