Pharmacovigilance Manager

11 drugs developed. 6 million courses of treatment. Immeasurable lives improved. Pharmacovigilance Manager Salary : £57,000 – £70,000 pa depending on experience plus benefits Reports to : Head of Quality, Regulatory & Pharmacovigilance Department : Research & Innovation Contract : 14 month fixed-term contract Hours : Full time 35 hours per week (other flexible-working requests will also be considered if it meets business needs) Location: Stratford, London with high flexibility (we would expect you to be in the office 1-2 days per week) OR Home based, UK Closing date : Wednesday 18th December at 23.55. This vacancy may close earlier if a high number of applications are received or once a suitable candidate is found, so please do not delay submitting your application to avoid any disappointment. At Cancer Research UK, we exist to beat cancer. We are professionals with purpose, beating cancer every day. But we need to go much further and much faster. That’s why we’re looking for someone talented, someone who wants to develop their skills , someone like you. We have an opportunity for a Pharmacovigilance Manager to join our Centre for Drug Development (CDD) on a maternity cover contract for 14 months. In this role you’ll be an expert in your field and lead a small Pharmacovigilance (PV) team responsible for the processing and reporting of safety information on our clinical trials. About the team The Cancer Research UK Centre for Drug Development (CDD) is the world’s only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in. What will you be doing? To act as line manager to the PV Team, ensuring the continued development of the team and managing resource to deliver on project requirements. Oversee procedures for collection, processing and reporting of serious adverse event, urgent safety measures and other safety information from clinical trials sponsored by the CDD as well as any safety information received from non-CDD sponsored clinical trials in compliance with ICH GCP and current legislation. System owner of the electronic safety database. To work with our Technology department to ensure appropriate selection, validation, maintenance and use in accordance with SOPs and regulatory guidelines. Maintain current version and licences for MedDRA and WHO Drug Dictionary. Monitor and ensure compliance of regulatory reporting of safety information. Ensure timely submission and quality of development safety update reports (DSURs). Ensure PV review of study documentation including but not limited to protocols (including lists of medically important events and reporting requirements as appropriate), relevant safety documents (Investigator brochures/SmPC), informed consent documents and clinical study reports. Oversee negotiation of safety exchange contracts with business partners. Respond to audit and inspection findings, identifying and implementing corrective and preventive actions as appropriate. Chair and co-ordinate Safety Review Meetings. Ensure prompt finalisation of minutes and communication of actions. What skills are we looking for? Degree in a scientific discipline or equivalent experience. Significant experience of working in Pharmacovigilance. Excellent knowledge of ICH GCP and applicable clinical trial regulations and guidance. Experience in working with safety databases. Experience in electronic regulatory submissions. Ability to maintain rigorous adherence to written procedures, guidelines and legal requirements. Good communication skills in order to liaise effectively with CRUK staff and external collaborators and authorities. Excellent attention to detail. Ability to influence others. Desirable Experience in early phase oncology trials. Awareness of current treatments, practices and safety issues surrounding cancer patient therapies. Please note: You must be eligible to work in the UK to apply for this vacancy. Cancer Research UK is not able to offer visa sponsorship. Our organisation values are designed to guide all that we do. Bold: Act with ambition, courage and determination Credible: Act with rigour and professionalism Human : Act to have a positive impact on people Together: Act inclusively and collaboratively We’re looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer. What will I gain? We create a working environment that supports your wellbeing and provide a generous benefits package, a wide range of career and personal development opportunities and high-quality tools. Our policies and processes enable you to improve your work-life balance, take positive steps in your career and achieve your personal wellbeing goals. You can explore our benefits by visiting our careers web page. How do I apply? We operate an anonymised shortlisting process in our commitment to equality, diversity, and inclusion. CVs are required for all applications; but we won’t be able to view them until we invite you for an interview. Instead, we ask you to complete the work history section of the online application form for us to be able to assess you quickly, fairly, and objectively. For more updates on our work and careers, follow us on: Linked In, Facebook, Instagram, Twitter and YouTube.