Role Profile Acting Pharmacovigilance Compliance Assessor, Pharmacovigilance Human Products Monitoring ROLE SUMMARY Reporting to the Pharmacovigilance (PV) Manager the Acting Pharmacovigilance Compliance Assessor works within the Human Products Monitoring (HPM) Department in relation to safety monitoring and Pharmacovigilance (PV)/Blood, Tissue & Cell and Organ (BTO) vigilance related activities. The role of the Acting Pharmacovigilance Compliance Assessor is to lead the technical team responsible for the systems in place to support safety monitoring of medicines and BTO vigilance activities, to ensure the HPRA obligations and requirements with regard to reporting are met in an appropriate and timely manner, to appropriately collate and present adverse reaction data and other vigilance reports, to provide input and support for responses to technical and other queries, to support team organisation and activities to achieve required levels of performance and to respond effectively to changes in the internal and external environment. The Acting Pharmacovigilance Compliance Assessor is responsible for implementation and maintenance of the quality management system for the PV section, including monitoring of quality across the section, interaction with HPM colleagues on quality related issues and overall liaison with the Quality Management System (QMS) department to implement and maintain quality management system policies and procedures to achieve the overall strategic objectives, performance and quality targets of the PV section. The Acting Pharmacovigilance Compliance Assessor is also responsible for the co-ordination of audit related activities for the PV Section. The Acting Pharmacovigilance Compliance Assessor works closely with the Compliance department, particularly the GCP/Pharmacovigilance Inspections, Market Compliance and BTO Groups. The Acting Pharmacovigilance Compliance Assessor works closely with the ICT department in relation to the operation, maintenance and updates to PV and BTO monitoring systems. The Acting Pharmacovigilance Compliance Assessor maintains effective working relationships with other areas of the HPRA, particularly the ICT, QMS and Compliance departments and will ensure that any required interactions are adequately defined, effectively managed and reviewed as appropriate.
KEY RESPONSIBILITIES - Strategic Objectives o Supporting the PV Management team in the day to day operation and ongoing development of the PV section o Working with the PV Management team in the preparation of work objectives for the PV section o Working with the PV Management team to prioritise work objectives and to ensure that the strategic and operational goals of the PV section are achieved o Providing support and direction to colleagues and others within the PV section and the HPM department o Working closely with the PV Manager and other members of the PV section/hpm department to ensure effective operation of the quality management systems and efficient delivery of work. o Identifying opportunities for continuous improvement by highlighting quality management issues. o Liaising with and providing technical information, advice and guidance on PV matters to HPRA and other regulatory colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public o Participating at all levels (internal, national and international) in the formulation and preparation of regulatory policies, guidelines, legislation and opinions o Representing the HPRA at national and international level, as required - Technical/Operational Objectives o Acting as the business owner for the PV/BTO vigilance systems and providing the main point of interaction between the PV section and the ICT department. o Managing data quality within the various vigilance systems utilised by the PV section. o Ensuring that information on the HPRA website with respect to reporting requirements for PV is kept up to date. o Monitoring and tracking HPRA and company/sponsor compliance with PV obligations and initiating action to address any issues identified o Providing expertise to the PV Manager and team through knowledge of quality management requirements and applications in order to maximise the available resources and the effectiveness of the section. o Proactively managing the implementation and maintenance of quality management in the PV section. o Identifying potential problems and providing solutions in a timely manner. o Working with the QMS department to ensure that quality management for PV/BTO vigilance is integrated and co-ordinated with the overall HPRA Quality Management System (QMS). o Preparation for and participation in PV compliance-related activities including proactive market surveillance and GCP/PV Inspections. o Compiling and providing information including national adverse reaction data to HPRA colleagues, to support responses to e.g. parliamentary queries and ministerial representations, freedom of information requests, legal, customer service and media queries, in accordance with the applicable timelines. o Contributing to the provision of data to facilitate responses to the European Medicines Agency (EMA) and other regulatory colleagues, pharmaceutical companies, WHO and 2
associated organisations, relevant national and international bodies, healthcare professionals and members of the public. o Compiling data and information for monthly departmental reports, the PV section of the annual report for the HPM department and the HPRA Annual Report. - Technical Management Database/IT: o Working with the ICT department to ensure appropriate systems are developed, implemented and upgraded as necessary to meet applicable recording and reporting standards and requirements. o Working with the ICT department to ensure that data received and recorded by the various PV/BTO vigilance systems is populated and maintained appropriately. o Working with the IT department to develop and implement appropriate system requirements to facilitate identification, tracking and monitoring of database related quality issues. o Working with the IT department to develop appropriate validation processes for relevant PV/BTO vigilance systems. o Conducting routine and ad-hoc internal and external database reviews to ensure availability of high quality data for stakeholders. Compliance: o Monitoring internal/company/sponsor compliance with PV reporting requirements and obligations including electronic reporting requirements. o Ensuring accurate and consistent use of nomenclatures; coding standards across the various PV/BTO systems, particularly HPRA data on EudraVigilance/WHO databases. o Ensuring appropriate maintenance and management of adverse reaction data (paper and electronic records). o Providing support for PV and GCP inspections. o Any other areas or processes, which may come within the scope of the PV section Quality and Knowledge Management: Implementing and maintaining a quality system in conjunction with the QMS section through: o Drafting and revising quality documentation e.g. standard operating procedures. o Ensuring a co-ordinated and controlled implementation of new and revised quality documentation. o Producing quality systems-related information for use and to monitor progress against plans. o Ensuring that appropriate quality policies and procedures are in place for compliance with European and national legislation, regulations and guidelines and with external QMS commitments. o Keeping current with HPRA key quality management activities as they impact on the PV section. Other: o Query handling. o Contributing to preparation, review and evaluation of cumulative PV data, as necessary. o Preparing pharmacovigilance activity reports. o Providing presentations to both internal and external stakeholders, as required 3
- Performance Management o Developing reporting schedules (with the IT department and PV section as appropriate) to contribute to the HPRA knowledge of data within the adverse reactions database e.g. data quality and reporting metrics. o Ensuring that quality management processes are continuously reviewed and amended, as required, to optimise the performance of the PV section. o Highlighting quality management performance issues to the PV Manager and contributing to the development of measures to resolve them. o Contributing to the development schedules for PV/GCP inspection schedules and market compliance activities. o Reporting regularly on progress against specified objectives, goals and targets. o Participating in the performance development programme (PDP). - Team Development and HR/People Management o Providing day to day support to all staff in the team. o Promoting a positive, open, friendly and professional working environment. o Overseeing the development and implementation of individual training plans for the team; and overseeing the maintenance of related training records and documentation. o Providing performance feedback, coaching and mentoring support to staff in the team. o Openly recognising good performance and promoting a culture of performance improvement in the team. o Working with the PV Manager to ensure the provision of adequate technical, nontechnical and continuous professional development for colleagues in the PV section and within the HPM department o Ensuring, in conjunction with the PV Manager, the provision of adequate training on quality systems and other areas for the PV section, as necessary. o Liaising with the HR department in providing front-line management of staff in relation to HR-related areas for team members. - General o Perform such other duties as the HPRA may reasonably required QUALIFICATIONS AND EXPERIENCE - To be considered for this post, candidates must have: o A primary degree in a relevant discipline, e.g. life sciences, data management etc. o A minimum of three years experience in pharmaceutical/clinical quality assurance, auditing and clinical data management including process improvement initiatives. o Experience with electronic reporting systems, database specification and development, coding standards and requirements, database searching and analysis skills o Detailed knowledge of relevant medicines legislation and guidelines. o Detailed knowledge of existing and planned standards impacting on reporting requirements. o Excellent data analysis skills. o Excellent communication, presentation, report writing and interpersonal skills. o Initiative and problem-solving abilities. o Proven ability to work as part of a multi-disciplinary team 4
- In addition to this the ideal candidate will have; o Post-graduate qualifications/training in pharmacovigilance, or other closely related scientific discipline o Knowledge and experience in pharmaceutical/clinical quality assurance, compliance, or clinical research o Demonstrable experience in people/project management REMUNERATION Salary: 59,427 per annum (*new entrants - incremental scale). SUPERANNUATION The new Single Public Service Pension Scheme ( Single Scheme ) commenced with effect from 1 January 2013. All new entrants to pensionable public service employment on or after 1 January 2013 are, in general, members of the Single Scheme. HOURS OF DUTY The hours of duty are fixed by the HPRA from time to time. The current arrangements are Monday-Friday (minimum 37 hours). Appointees are eligible to participate in the flexitime arrangements after a period of six months. DURATION OF POST This is a one year contract post (as a consequence of Maternity Leave). ANNUAL LEAVE Annual leave (exclusive of usual public holidays) is 22 days per annum. DUTIES OF POST The duties set out in the role profile (above) are indicative of responsibilities related to this role. As with all posts, the nature of HPRA business is evolving and flexibility is required in order to adapt to changing business needs. CONFIDENTIALITY AND CONFLICT OF INTEREST Employees are prohibited from having any personal or financial interest in any industry that the HPRA regulates from the date of appointment with the HPRA. The HPRA deals with highly confidential matters including identifiable details pertaining to healthcare professionals, patients and commercially sensitive information. Employees are prohibited from disclosing any 5
information in relation to the business of any person obtained in his/her capacity as an officer of the HPRA. VOLUNTARY HEALTH INSURANCE SCHEME A group scheme operates for those wishing to participate and contributions are deducted from salary. REFERENCES The names and addresses of two referees to whom the applicant is well known but not related must be submitted with the application. Reference may be made to current and former employers without further notification of the applicant. Applicants having any reservations on this matter should so state at time of application. CLOSING DATE The closing date for applications for this post is Sunday 1 st November 2015. INTERVIEWS Applicants attending for interview may be required to prepare a presentation-details will be notified to applicants who are shortlisted. It is anticipated that interviews for this post will take place in the week beginning 16 th November 2015. Note: The HPRA is not in a position to reimburse expenses incurred by candidates attending for interview. COLLECTIVE AGREEMENT: REDUNDANCY PAYMENTS TO PUBLIC SERVANTS The Department of Public Expenditure and Reform introduced, with effect from 1st June 2012, a Collective Agreement which had been reached between the Department of Public Expenditure and Reform and the Public Services Committee of the ICTU in relation to ex-gratia Redundancy Payments to Public Servants. It is a condition of the Collective Agreement that persons availing of the agreement will not be eligible for re-employment in the public service by any public service body (as defined by the Financial Emergency Measures in the Public Interest Acts 2009 2011) for a period of 2 years from termination of the employment. Thereafter the consent of the Minister for Public Expenditure and Reform will be required prior to re-employment. People who availed of this scheme and who may be successful in this competition will have to prove their eligibility (expiry of period of non-eligibility) and the Minister s consent will have to be secured prior to employment by any public service body. 6
DECLARATION Applicants will be required to declare whether they have previously availed of a public service scheme of incentivised early retirement and/or the collective agreement outlined above. Applicants will also be required to declare any entitlements to a Public Service pension benefit (in payment or preserved) from any other Public Service employment and/or where they have received a payment-in-lieu in respect of service in any Public Service employment. * Candidates should note that entry will be at the minimum of the scale and the rate of remuneration may be adjusted from time to time in line with Government pay policy. 7