Patient Safety Specialist

Patient Safety Specialist Location: London Pancras Square - 3 days on site About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death. Come and join our AZ team where you will play a pivotal role in this exciting period of development!! This role will provide a high quality, comprehensive, technical and scientific pharmacovigilance service in the management and day-to-day processing of pharmacovigilance activities. In addition to this, it will also provide knowledge and expertise to internal and external customers on all aspects of Patient Safety relating to AstraZeneca UK (AZUK) activities and fully comply with Good Pharmacovigilance Practice (GVP) requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and Standards. Key Responsibilities: Work closely with the AZUK Adverse Event (AE) Case Handling team to ensure all AEs originating in the UK are reported to the Global Patient Safety Data Entry Site (DES) in compliance with internal procedural documents. Resolve queries related to Individual Case Safety Report (ICSRs) raised by the AZUK Case Handling team and/or DES. Maintains oversight of ICSRs data entry into the local database, and assist with case assessments where required. Oversee AE follow-up activities, to ensure that Healthcare Professional (HCPs), Patients and other reporters of AEs receive follow-up within the required timelines. Monitor the Patient Safety Shared Inbox and ensure that emails, including AEs are appropriately triaged or actioned within a timely manner. Act as a liaison with 3rd party companies with whom AstraZeneca has licensing agreements, divestments and/or acquisitions. Review and input (as appropriate) into materials related to Patient Support Programmes and Market Research activities for compliance with pharmacovigilance legislations. Triage Product Quality Complaints arising from applicable pharmacovigilance projects and forward these to medical information for onward processing. Ensures that all local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF). Work alongside the Patient Safety Manager in the management of applicable pharmacovigilance projects Support the Patient Safety Manager in delivering the strategy of the Patient Safety team across the AZUK. Support the Patient Safety Manager and wider business with the implementation of any applicable additional Risk Minimisation or Pharmacovigilance activities. This may include supporting the drafting of Local RMP documentation. Analyse and input into process and procedure improvements. Create procedural documents or guidelines applicable to any pharmacovigilance projects / processes as directed by the Patient Safety Manager. Responsible for understanding and working to all relevant procedural documents, legislation and applicable codes and maintaining an accurate and up to date personal training record. Maintains oversight of all safety related processes, issues and brand activities within AZUK, including risk management plans and associated activities. Ensures compliance with both AZ requirements and global and local regulatory requirements for patient safety and ensures corrective and preventative actions are taken in the event of local non-compliance. Requirements: Life science degree or appropriate professional qualifications. Experience within pharmacovigilance. Demonstrable knowledge of legislation governing pharmacovigilance in the UK. Experience of the pharmaceutical or healthcare industry. Experience of external customer interaction. Ability to effectively influence and interact with cross-functional colleagues. Desirables: Experience of working in pharmacovigilance at a marketing company level. Project management skills. Experience of authoring and implementing Risk Management Plans AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. So, what’s next: Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you! *** We will be reviewing applications and shortlisting on a rolling basis - as such we reserve the right to withdraw this vacancy ahead of the stated closing date Competitive salary and benefits package on offer. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package. Date Posted 03-Oct-2023 Closing Date 28-Oct-2023 When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process. You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.