Closing date for applications: 26/06/2022
Role Summary
Reporting to the Director of Human Products Monitoring, the role of the Vigilance Assessment (VGA) Manager is to lead a team within the vigilance assessment section, responsible for post-market surveillance activities of human medicines that have been authorised or licensed for use in Ireland.
Post-market surveillance activities employ a range of tools to monitor the safety of medicines, and which include the assessment of reports of suspected adverse events, conducting periodic safety reviews and signal management activities, evaluating new and emerging data from a variety of data streams as well as risk management planning for medicinal products and risk communication in co-operation with pharmacovigilance professionals in Europe and internationally.
The VGA section of the HPM department is comprised of two teams, each with a VGA Manager. The VGA managers, report to the Director of Human Products Monitoring, and direct, support and lead their respective teams to achieve required levels of performance. The VGA managers work together to ensure seamless integration of activities, and achievement of shared objectives and goals, and together develop the sections activities and capabilities, through fostering a culture of scientific development, responding effectively to changes in the internal and external environment.
Key Responsibilities of the role
Strategic Management:
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Supporting the Director of HPM in the management and ongoing development of the department, which may encompass identification of strategic objectives for VA and related areas, as well as implementation of reform measures and change initiatives to support the organisation’s approach to oversight of regulatory activities for human medicines.
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Working with colleagues in the HPM management team to prioritise objectives and to ensure that the strategic and operational goals of the Department are achieved.
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In partnership with the other VGA Manager, developing strategic and operational plans for the VGA section that deliver a patient focussed and risk centred system of regulation, focussed on proactive and preventative measures and that is consistent with those of the Department and the wider HPRA. For this post, the VGA Manager will lead on strategic plans related to HPRAs representation at EMAs Pharmacovigilance & Risk Assessment Committee.
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Managing and developing staff, including through change and development initiatives and providing a supportive environment to enable a motivated, impactful and adaptable team.
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Provide technical leadership in relation to handling of vigilance issues of public health relevance and in supporting strategic risk management and communication.
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Working with colleagues in the HPM department to ensure effective and timely implementation of new legislation and guidance relevant to the department activities and to ensure relevant systems, processes and resources are in place to undertake these activities.
For more information please refer to the role profile below. Applications (Application form and CV) should be sent directly to our recruitment inbox jobs@hpra.ie
Role Profile Application form