ph3Career Category /h3pSafety /ph3Job Description /h3pIf 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. /ph3GLOBAL SAFETY MANAGER (COUNTRY SAFETY LEAD SWITZERLAND) /h3pLIVE /ph3What you will do /h3pIn this vital role as a Global Safety Manager/Country Safety Lead Switzerland you will manage Swiss Pharmacovigilance activities and act as the local safety responsible person for Switzerland (Pharmacovigilance responsible Person, medicinal products for human use). This is a hands‑on role for an experienced PV professional who can work independently, manage local safety requirements with confidence, and represents Safety as a trusted partner within the Swiss affiliate. The role holds the PV responsibility for marketed products as well as products in clinical trials, has no direct reports, but requires excellent people skills, strong stakeholder management and the ability to influence without formal authority. The position works closely with colleagues in Germany and Austria for back‑up and alignment and interacts regularly with Amgen’s international safety team worldwide. The job holder will be based in Rotkreuz, Switzerland. /ph3Key Activities: /h3ulliManage Swiss local Pharmacovigilance activities in line with Swiss legislation, Amgen procedures and expectations /liliAct as the local Safety subject matter expert and key PV contact for the Swiss affiliate /liliEnsure timely and compliant handling of adverse event information, local literature reviews, safety reporting obligations, urgent safety communications and risk minimization activities /liliPharmacovigilance responsible Person, medicinal products for human use /liliMaintain Swiss country‑specific safety procedures, local requirements and relevant documentation /liliSupport inspection readiness and act as point of contact for health authority inspections and internal audits within the role’s area of responsibility /liliMonitor local compliance, identify issues and support appropriate follow‑up, including CAPAs where needed /liliPartner closely with Commercial, Medical, Regulatory, Quality, Legal, Market Access and other affiliate functions to ensure PV requirements are understood and embedded in local activities /liliReview local programs, vendor contracts, patient support programs, market research activities and partner arrangements from a PV perspective /liliCoordinate back‑up arrangements and operational alignment with Germany and Austria /liliRepresent Switzerland in regional and global safety discussions and contribute to best‑practice sharing /li /ulh3WIN /h3h3What we expect of you /h3pWe are all different, yet we all use our unique contributions to serve patients. We are seeking an experienced PV professional who combines strong technical expertise with excellent collaboration and communication skills: /pulliUniversity degree in life sciences, pharmacy, medicine, veterinary medicine or another relevant scientific/healthcare discipline /liliAdvanced degree or healthcare professional qualification preferred /liliSignificant experience in Pharmacovigilance, preferably in a pharmaceutical or biotech affiliate environment /liliExperience as Local Safety Officer, Country Safety Lead or equivalent role /liliStrong understanding of Swiss PV requirements and good knowledge of EU/global PV expectations for both post marketing and for clinical trials /liliAbility to work independently and manage Swiss PV tasks without day‑to‑day supervision /liliStrong stakeholder management skills and confidence working with Commercial, Medical, Regulatory, Quality and other affiliate partners /liliAbility to explain PV requirements clearly, pragmatically and in a business‑relevant way /liliExperience with audits, inspections, CAPAs and inspection readiness /liliStrong organizational skills, accountability and attention to detail /liliExperience with vendor oversight is an advantage /liliExcellent written and verbal communication skills in English as well as fluency in German; French and/or Italian language skills would be a plus /li /ulpThis role is critical to patient safety, PV compliance and the reputation of Safety within the Swiss affiliate. We are looking for someone who is technically strong, independent, collaborative and confident, a person who can manage the details while building strong relationships and making Safety a respected partner in the business. /ph3THRIVE /h3h3What you can expect of us /h3ulliVast opportunities to learn and move up and across our global organization /liliDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act /liliGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits /li /ulh3Equal opportunity statement /h3pAmgen 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. 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
Global Safety Manager (Country Lead) Arbeitgeber: Biopharma Careers
Novartis ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, aktiv an der Qualität innovativer pharmazeutischer Produkte mitzuwirken. Mit einem starken Fokus auf persönliche und berufliche Entwicklung, flexiblen Arbeitsmodellen und einem integrativen Arbeitsumfeld fördert Novartis nicht nur Ihre Karriere, sondern auch Ihr Wohlbefinden. In Kundl, Österreich, profitieren Sie von einem dynamischen Team und einer Unternehmenskultur, die Vielfalt und Inklusion schätzt.