Senior Associate Global Safety (Local Safety Switzerland) in Zug

ppIf you feel like you're part of something bigger, it's because you are. At Amgen our shared mission to serve patients drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together, researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It's time for a career you can be proud of. Join us. /p h3bSENIOR ASSOCIATE GLOBAL SAFETY (LOCAL SAFETY SWITZERLAND) /b /h3 h3bLIVE /b /h3 pbWhat you will do /b /p pIn this vital role as a bSenior Associate Global Safety (Local Safety Switzerland) /b you will support local pharmacovigilance activities in Switzerland and support provision of safety expertise to the local business. You will conduct core safety activities including data collection, processing, distribution and regulatory submission, based on appropriate training and assigned roles within the safety database and related systems. You will maintain compliance with Swiss legislation, Amgen policies and procedures, support the Safety Manager across the full range of local safety activities, and contribute safety expertise to local medical teams and cross-functional activities. The ability to identify, prioritize and elevate safety issues is important. /p pThe role works closely with colleagues in Germany and Austria and interacts regularly with Amgen's international safety team worldwide. The job holder will be based in Rotkreuz, Switzerland. /p pbKey Activities: /b /p ul liSupport Swiss local pharmacovigilance activities in line with Swiss legislation, Amgen procedures and expectations /li liMaintain current knowledge of and compliance with Swiss safety regulations and work with the Safety Manager to keep local affiliate safety requirements up to date in SOPs, manuals and reporting requirements /li liSupport timely and compliant handling of adverse event information, local literature reviews, safety reporting obligations, urgent safety communications and risk minimization activities /li liAssist in the training on adverse event reporting obligations for local staff and/or relevant business partners /li liSupport inspection readiness, inspections and internal audits within the role’s area of responsibility /li liSupport the alignment with Commercial, Medical, Regulatory, Quality, Legal, Market Access and other affiliate functions that PV requirements are understood and embedded in local activities /li liSupport the review of local programs, vendor contracts, websites/social media projects, patient support programs, market research activities and partner arrangements from a PV perspective /li /ul h3WIN /h3 pbWhat we expect of you /b /p ul liUniversity degree in life sciences, pharmacy, medicine, veterinary medicine or another relevant scientific/healthcare discipline /li liExperience in pharmacovigilance, preferably in a pharmaceutical or biotech affiliate environment /li liPractical understanding of Swiss PV requirements for both post marketing and for clinical trials /li liExperience with Pharmacovigilance Audits and Inspections is an advantage /li liStrong organizational skills, accountability and attention to detail /li liStakeholder management skills and confidence working with Commercial, Medical, Regulatory, Quality and other affiliate partners /li liAbility to identify, prioritize and elevate safety issues, with sound problem-solving abilities /li liConfident in handling core operational safety activities (when trained) /li liExcellent written and verbal communication skills in English as well as fluency in German; French and/or Italian language skills would be a plus /li /ul pThis role is important to patient safety and Pharmacovigilance compliance in Switzerland, ensuring reliable execution of local safety activities while supporting strong collaboration and embedding Safety expertise across the affiliate. /p h3THRIVE /h3 pbWhat you can expect of us /b /p ul liVast opportunities to learn and move up and across our global organization /li liDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act /li liGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits /li /ul pEqual opportunity statementbr/Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.br/We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation. /p /p #J-18808-Ljbffr