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PV Quality Management and Compliance Manager - Dublin, Dublin
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Client:
Aspen Pharma Group
Location:
Dublin, Ireland
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
c9b2fe9cf492
Job Views:
4
Posted:
16.06.2025
Expiry Date:
31.07.2025
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Job Description:
* Oversees 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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