Risk Management Officer en Astellas

Risk Management OfficerAbout Astellas:At Astellas we are making treatments that matter to people.We are tackling the toughest health challenges putting the patient at the heart of every move we make.Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.The Opportunity:Join Astellas Pharma as a Risk Management Officer in the United Kingdom, where you will play a pivotal role in shaping the future of healthcare. In this hybrid position, you will provide clinical, methodological, and strategic input to global project and product management teams, ensuring the effective implementation of risk management strategies throughout the lifecycle of our innovative therapies. Your contributions will directly impact patient care and help us fulfill our mission to "Change Tomorrow™.”You will be part of an inclusive team that works to develop innovative therapies for patients.Hybrid Working:At Astellas, we recognise that our employees enjoy having a balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.Key Activities for this role:Provide clinical and strategic support in the development and maintenance of project-related risk management strategies, ensuring alignment with global and local regulatory requirements.Collaborate closely with Epidemiology and Signal Management Officers to advance scientific methodologies for risk evaluation and signal detection.Ensure accurate representation of risk management strategies in aggregate safety reports, including Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).Contribute to the development of innovative approaches for assessing the effectiveness of risk mitigation measures.Organize and deliver administrative support to governance committees, ensuring timely and routine updates on risk management activities.Essential Knowledge & Experience:Extensive experience in the pharmaceutical industry, including a strong background in global risk management practices.Deep understanding of ICH guidelines and regulatory requirements in the US and EU related to pharmacovigilance.Excellent interpersonal skills, with a proven ability to collaborate effectively across cultures and functional areas.Demonstrated leadership in cross-functional teams, particularly in the execution and oversight of risk management activities.Proficient in Microsoft Office Suite and fluent in English, both written and spoken.Preferred Experience:Experience in Drug Safety, Epidemiology, or Clinical Development.Familiarity with global safety reporting regulations and guidelines.Education/Qualifications:Bachelor’s degree in health-related sciences degree (MD, PhD/PharmD) or equivalent.Additional Information:This is a full-time, permanent role.This is located in Addlestone, UK office.This position follows our hybrid working model. The role requires a blend of home and a minimum of 1 day per quarter in our UK office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.What We Offer:A challenging and diversified job in an international setting.Opportunity and support for continuous development.Inspiring work climate.We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.#LI-Hybrid#LI-Addlestone#LI-MO1 Solicitar ahora