Senior Associate Global Safety

2 weeks ago


Cambridge, United Kingdom Amgen Full time

Career CategorySafetyJob DescriptionHOW MIGHT YOU DEFY IMAGINATIONIf you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.SENIOR ASSOCIATE GLOBAL SAFETYLIVEWhat you will doIn this vital role you will be responsible for ensuring adherence to Amgens regulatory commitment for pharmacovigilance. You will perform a wide variety of drug safety activities within the UK and Ireland affiliate working with both local and global colleagues and based on sound knowledge of pharmacovigilance regulations and company procedures.Pharmacovigilance Legislation: Maintains own current knowledge of and compliance with local safety regulations.Case management: Perform business critical core safety activities per legal deadlines including intake of AE reports follow up with HCPs for complete data ICSR & aggregate safety report submission to regulators. Handling safety enquiries received to the departmental inbox from both internal and external stakeholders. Review metrics to monitor MHRA & HPRA submission compliance.Periodic Reporting: Assist with submission of DSUR and PSUR safety reports to Regulators and Ethics Committees where applicable. Perform review of relevant PSUR safety signals for MHRA notification.Risk Management: Support for safety risk communications (e.g. Dear Investigator Letter Urgent Safety Measures Risk Minimisation Materials etc) and Risk Management Plans in conjunction with Regulatory Affairs Clinical and Medical Departments.Training: Delivers safety reporting training for local affiliate staff and external service providers.Key contact: Serves as key contact for defined safety activities within the affiliate. Provides expert safety input into various cross-functional initiatives e.g. Patient Support Programs Market Research Digital Media Projects local Study Protocols etc to ensure compliance while understanding local business needs.Be part of our teamYou would be joining the UK & Ireland Safety Team based in the local affiliate and collaborating with other affiliate functions and also with Global Patient Safety colleagues to meet business needs. Together with team members you would conduct business critical safety tasks provide support to audits and inspections and assist the Senior Global Safety Manager with activities and issue resolution where necessary. Within the team you would maintain awareness of safety profiles and new risk information for designated Amgen products to support product safety activities.WINWhat we expect of youWe are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:Graduate with life science or healthcare degree and proven relevant industry experience within post market and clinical trial pharmacovigilance.Use of MS Office products to a proficient standard Word Excel PowerPoint.Demonstrable knowledge of processes and regulations in pharmacovigilance.Experience with Safety Databases.Natural team player with the personal qualities to relate well to people at all levels.Aptitude for analytical thinking with a methodical approach and unquestionable attention to detail.Highly motivated quick to learn with ability to work effectively under own initiative and a strong drive for excellence.THRIVEWhat you can expect of usAs we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health finance and wealth work/life balance and career benefitsFlexible working from home options availableApplication close date: 21st November 2025APPLY NOWfor a career that defies imaginationIn our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us.Equal Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to your race colour religion sex sexual orientation gender identity national origin protected veteran status or disability status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation..Required Experience:Senior IC Key Skills Beauty And Fashion,EMC,Jewellery,Arabic English Translation,Business Analytics Employment Type : Full-Time Experience: years Vacancy: 1



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