Pharmacovigilance Administrator (Cambridge) Cycle Company: Cycle Pharmaceuticals Ltd Position Summary: This full-time position is within the Product Development & Regulatory Affairs team working in our Cambridge office on a hybrid basis (minimum 3 days in the office). Are you detail-driven and an organised person who is looking for an opportunity to work within the pharmaceutical industry? Were looking for a Pharmacovigilance Administrator to play a key role in the smooth running of our PV operations here at Cycle. This is an important position within the team as, youll manage day-to-day pharmacovigilance administrative activities, support the development and upkeep of our PV systems, and ensure compliance with regulatory standards. Youll collaborate closely with various other departments in the business while also liaising with external PV subcontractors and strategic partners to keep our safety systems sharp and responsive. This is an exciting opportunity for someone who has strong administration skills with a keen interest in the pharmaceutical industry and a passion to learn more about PV. Our Company At Cycle, we believe that Every Single Patient Matters . This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen. Our core focus areas include rare metabolic, immunological, and neurological genetic conditions, where we improve existing drugs, repurpose them for new uses, and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice. If you want to know more about what we do then, why not check out our website below and look at some of our patient stories: Patient Stories - Cycle Pharma What youll be doing in this role: Provide administrative assistance with safety data exchange. Supporting safety data reconciliation activities. Prepare and organise periodic meetings with QPPV and circulate minutes/actions. Support on general administrative tasks such as setting up meetings and taking minutes. Ensure audit readiness: ensuring that all the accountable activities are audit ready at any time. Support review and updates to relevant SOPs and WIs. Monitor the Pharmacovigilance inbox. Provide administrative assistance during Cycles internal audits and partner PV audits. Provide support in pharmacovigilance metrics drafting, following written procedures and instructions. Perform periodic reconciliation of Cycles logged complaints with PV service provider, following written procedures and instructions. Ensuring documents shared with PV service provider remain up to date. Perform periodic checks of EMA EURD List. Complete weekly phone line monitoring. Update and maintain PV-related spreadsheets. Support monitoring activities related to Health Authority Commitments. The following skills and experience will be important in helping set you up to succeed and thrive in this role: Previous administration experience, preferably within a regulated industry. Life Science degree would be beneficial and support you in this role but is not essential. Excellent communication skills to build relationships across the business. Ability to work in a proactive and autonomous manner, as well as being part of a team. Good time management skills with a high level of attention to detail and quality. Strong analytical, organisational and problem-solving skills. Willing to learn new processes and work to procedures set within the business. Proficiency with the Microsoft Office suite, including Word, Excel, Access and PowerPoint. Ability to manage a range of tasks at any one time and prioritise own workload. What can we offer to you: In addition to being part of a great team and doing things that will make a real difference to patients lives, you will enjoy all the benefits that brings: Competitive salary based on experience A collaborative high performing work environment Performance based bonus Opportunity to join a fast growing and ambitious business Company pension scheme 100% employer paid membership for Private Health Insurance Life and Critical Illness Insurance Corporate Gym membership Regular team building events and an agile working environment Cycle Pharmaceuticals 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.
Job Title
PV Administrator