Pharmacovigilance and Quality Assurance Officer

NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It was set up to provide a single interface for those wishing to conduct clinical trials within the partner organisations, and to ensure that there are common, efficient processes for the set up and administration of clinical trials. About the role: The Pharmacovigilance and Quality Assurance Officer will support the safe and compliant conduct of sponsored clinical trials by combining day-to-day pharmacovigilance activity with maintenance of the Clinical Trials Office quality management system. The post holder will work closely with the Non-Commercial Trials Manager, Clinical Trials Associates, trial teams, investigators and colleagues across KHP partner organisations. The role will support the review, quality control and onward reporting of safety information; maintenance of safety reporting schedules and records; preparation and submission of regulatory safety reports; maintenance and review of standard operating procedures (SOPs), work instructions and controlled templates; quality control and audit activity; corrective and preventive action (CAPA) tracking; and staff quality related training. The KHP-CTO offers hybrid working with staff being able to work between the office and home, a minimum of 2 days working in the office at Guy’s campus is expected for this role (subject to annual review). You will be offered a full-time contract (35hrs) for 24 months. About you: To be successful in this role, we are looking for candidates to have the following skills and experience: Essential criteria Relevant degree, professional qualification, or equivalent experience in biomedical/life sciences, clinical research or a related field. Relevant experience in clinical trials or clinical research, including experience in at least one of the following clinical quality assurance, pharmacovigilance or research governance. Experience of developing and implementing new SOPs, policies or work instructions. Excellent working knowledge of Good Clinical Practice and current UK clinical trial/research regulatory requirements, with the ability to apply requirements to day-to-day work. Experience of maintaining accurate controlled records, databases, trackers or quality documentation, with demonstrably high levels of accuracy and attention to detail Ability to review and assimilate complex clinical or regulatory information, identify discrepancies and produce clear written documentation or report Excellent organisational and time-management skills, with the ability to prioritise competing workloads and meet time-critical regulatory deadlines. Strong written and verbal communication skills, with the ability to work collaboratively and provide clear advice to colleagues and stakeholders. Desirable criteria Practical experience of pharmacovigilance in clinical trials, including SAE/SUSAR processing and reporting DSURs and SUSARs to regulatory bodies. Experience of, or demonstrable understanding of, MedDRA coding Experience of quality management systems, SOP/document control, audit, quality control or CAPA tracking in a clinical research environment. Experience of developing audit plans and conducting audits. Downloading a copy of our Job Description Full details of the role and the skills, knowledge and experience required can be found in the Job Description document. Further Information At King’s, we believe that the diversity of our community and a culture that is welcoming, open, inclusive and collaborative, are great strengths of the university. The Equality Act of 2010 protects the rights of our students and staff and provides a framework to fulfil our duties to eliminate unlawful discrimination, harassment and victimisation. £45,829 to £53,462 per annum, including London Weighting Allowance