Please note that this job is open only to current members of staff of Cardiff University who are eligible for redeployment. Specialist in Pharmacovigilance & Safety Centre for Trials Research (CTR) College of Biomedical & Life Sciences The Centre for Trials Research at Cardiff University is a large, multinational community of researchers, professional services staff and students from a diverse range of backgrounds. We tackle the big diseases and health concerns of our time by forming partnerships with researchers and building lasting relationships with the public. An opportunity has arisen for a Specialist in Pharmacovigilance & Safety to join the Centre for Trials Research. We are seeking a Specialist in Pharmacovigilance & Safety to ensure the accurate entry, coding and reporting of all pharmacovigilance and safety data, and to provide support and advice to the trial teams on the pharmacovigilance and safety requirements dictated by the Clinical Trials Regulations. You should have a Degree/NVQ 6 or equivalent Professional membership/experience, substantial experience of working within a research or clinical trials environment, with demonstrable administrative experience, and the ability to work unsupervised to deadlines, planning and setting priorities for own work and that of others and monitoring progress. Applications from graduates (or equivalent experience) with excellent administrative skills are encouraged. Experience of working in Pharmacovigilance & Safety, research governance or quality assurance environment is advantageous, however training will be available. We would also be delighted to hear from you if you feel that you have equivalent qualifications or experience not specifically mentioned here. With a culture of continuous professional and career development the Centre has an excellent track record of helping people develop in their areas of interest, with many progressing within the Centre itself, the wider University or further afield. For informal discussions you are welcome to contact the recruiter (Kathryn Hollands, Senior Pharmacovigilance & Safety Specialist) on HollandsK1Cardiff.ac.uk This is a full-time (35 hours per week), fixed term post for 12 months. Salary: £33,232 - £35,880 per annum (Grade 5). The majority of roles at Cardiff University are currently operating under “blended working” arrangements, with staff having the flexibility to work partly from home and partly from the University campus depending on specific business requirements. Discussions around these arrangements can take place after the successful candidate has been appointed. Cardiff University offers many excellent benefits, including 45 days annual leave (incl bank holidays), local pension scheme, a cycle to work scheme and other travel initiatives, annual increments within the pay scale, and more. It is an exciting and vibrant place to work, with many different challenges and is a proud Living Wage supporter. Closing date: Friday, 24 January 2025 Please be aware that Cardiff University reserves the right to close this vacancy early should sufficient applications be received. Cardiff University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds. We therefore welcome applicants from all sections of the community regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. In supporting our employees to achieve a balance between their work and their personal lives, we will also consider proposals for flexible working or job share arrangements. Applications may be submitted in Welsh, and an application submitted in Welsh will not be treated less favourably than an application submitted in English. Job Purpose Support the University within Pharmacovigilance & Safety, carrying out supporting work, providing advice, guidance and support, and leading projects within this area Duties and Responsibilities Key Duties • Provide professional advice and guidance on Pharmacovigilance & Safety, processes and procedures to internal and external customers, using judgement and creativity to suggest the most appropriate course of action, and ensuring complex and conceptual issues are understood • Investigate and analyse specific issues within Pharmacovigilance & Safety, creating recommendation reports, supported by advances within Pharmacovigilance & Safety • Ensure that the provision of Pharmacovigilance & Safety is delivered to the institution, proactively changing the delivery according to customer requirements • Collaborate with others in order to make recommendations for development of established processes and procedures • Establish working relationships with key contacts, developing appropriate communication links with the University’s Schools/Directorates and outside bodies as required • Create specific working groups from colleagues across the University to achieve Centre for Trials Research objectives • Supervise specific project teams on an occasional basis to accomplish key objectives • Develop and deliver training within Pharmacovigilance & Safety • Undertake a variety of administrative duties to support the department • Instruct and guide other employees across the University within Pharmacovigilance & Safety as required General Duties • Ensure that an understanding of the importance of confidentiality is applied when undertaking all duties • Abide by University policies on Health and Safety and Equality and Diversity • Perform other duties occasionally which are not included above, but which will be consistent with the role IMPORTANT: Evidencing Criteria It is the School of Medicine's policy to use the person specification as a key tool for short-listing. Candidates should evidence that they meet ALL of the essential criteria as well as, where relevant, the desirable. As part of the application process you will be asked to provide this evidence via a supporting statement. Please ensure when submitting this document / attaching it to your application profile you name it with the vacancy reference number, in this instance for this post, 19660BR. If candidates do not provide written evidence of meeting all of the essential criteria then their application will not be progressed. The School of Medicine welcome the submission of CVs to accompany evidence of the job-based criteria. Essential Criteria Qualifications and Education 1. Degree/NVQ 4 or equivalent Professional membership/experience Knowledge, Skills and Experience 2. Substantial experience of working within specialist discipline 3. Able to demonstrate professional knowledge within specialist discipline to give advice and guidance to internal and external customers 4. Ability to set up standard office systems and procedures and make improvements as appropriate Customer Service, Communication and Team Working 5. Ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people 6. Evidence of ability to explore customers’ needs and adapt the service accordingly to ensure a quality service is delivered Planning, Analysis and Problem solving 7. Evidence of ability to solve expansive problems using initiative and creativity; identifying and proposing practical solutions and resolving problems with range of potential outcomes 8. Evidence of demonstrable knowledge of key advances within specialist discipline 9. Evidence of ability to work unsupervised to deadlines, planning and setting priorities for own work and that of others and monitoring progress. Other 10. A willingness to undertake further training and development Desirable Criteria 11. Postgraduate/Professional qualification 12. Experience of working in a Higher Education environment 13. Fluency in Welsh, written and oral