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PV Quality Management and Compliance Manager - Dublin
Aspen Pharma GroupDublin, IE30+ days ago
Job descriptionOversees the management of APTL Pharmacovigilance (PV) Quality Management and Compliance (QMC) System for Aspen Group and local products in Europe on behalf of EU QPPV Responsible for PV Quality Management System (QMS), auditing and PV self-inspection Direct line-manage APTL PV QMC team Ensures that adequate procedures and systems are in place for all European Pharmacovigilance activities to be carried out by Aspen in line with EU regulations on behalf of EU QPPV Cooperates with Head of Medical Governance at APTL & Pharmacovigilance Liaison responsible for the outsourced PV activities to ensure that the processes followed by the vendors and compliance with EU regulations is maintained Manage delegated tasks from EU QPPV on a defined and ad hoc basis Appropriate Quality Management Systems are utilized both internally and externally (in the case of affiliates), in compliance with group policies and procedures and national / EU legislation and guidelines. Quality Management systems reflect industry best practice with the aim of achieving continuous improvement. Support safety data reporting processes and procedures (working with appropriate and relevant divisional management) to ensure compliance with national legislation, Support all PV functions and affiliates in ensuring compliance. Ensure that detailed systems and procedures are in place in accordance with Aspen Group Guidelines, Policies and Procedures and relevant guidelines of external regulatory and professional organizations Ensure SOP’s and WI are identified, developed, implemented and maintained, relevant to QMS functions for PV department Partners with Pharmacovigilance functions in the region to ensure GVP compliance. Assists in identifying and communicating pharmacovigilance-related risks and opportunities for process improvement. Provide training on QMS policies and procedures for all appropriate personnel and departments on a continuous basis. Compiles monthly and annual compliance reports and document and investigate all non-compliances and deviations, identify trending on root causes and ensure responsible persons / departments implement adequate and timeous corrective and preventative action (CAPA) Manage and minimize risk to the company by applying risk management principles and procedures. Update and maintain APTL risk register with regards to risks from PV Department Maintenance of the Pharmacovigilance System Master file (PSMF). Responsibility for supporting and mentoring personnel in compliance related activities and tasks and supporting supervision of operations across PV group. Helps to ensure that the Safety Database is functional, operates optimally and proactively by supporting the implementation of updates and changes. Oversight of compliance to SDEA’s from affiliates and Distributors Ensure PV records and document management in line with Aspen In Europe processes Oversight of compliance tracking of all PV KPIs. Analyse trends, identify areas of weaknesses / gaps and recommend corrective actions Responsibility to monitor PV service providers compliance as per way of working document / SLA. Reporting of Key Performance Indicators and all PV metrics in periodic reports. To keep colleagues and Group informed of any relevant new information (including updates to EU legislation) Involvement with international group projects and task forces in any area, as required. Conducting PV audits and self-inspection and act as PV SME during GMP, RA or MI audits of the affiliates / vendors, as required Provide support for audits / inspections (for example, preparation / readiness, coordination, back room, front room, responses). Communicate audit results to internal stakeholders and prepare audit reports. Assess audit responses and ensure closure of corrective and preventive actions (CAPAs). Ensure that Partners and Affiliates responsible for performing PV tasks or handling safety data are regularly audited
Other responsibilities :
- Adherence to Company Health & Safety procedures
- Participate in training programmes
- Compliance with relevant Aspen company policies, guidelines and procedures
- Awareness of Aspen Goals and Objectives
- Awareness of PV goals and objectives and aim to achieve them
- Work towards the continuous development and improvement of the department
- Effective utilization of resources (this includes financial impact)
- Any other duties as assigned by your manager
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Compliance Manager • Dublin, IE