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Global Safety Medical Director- Global Safety Officer US-Remote

Company: Amgen
Location: Thousand Oaks
Posted on: January 9, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?If 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.Global Safety Medical DirectorLiveWhat you will doLets do this. Lets change the world. In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for the assigned development product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities and will be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will also lead the Safety Analysis Team (SAT) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). In addition, you will participate as a member of the Evidence Generation Team and other relevant cross functional teams and will be assigned as delegate for the Therapeutic Area Head (TAH) and have management of Global Safety Physicians.Key Activities:Validate safety signals and lead safety signal assessmentsDevelop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)Prepare/review core and regional risk management plans including additional risk minimization measuresPrepare/review safety sections of periodic aggregate reportsProvide safety input to protocols, statistical analysis plans, and clinical study reportsPrepare/review safety sections of new drug applications and other regulatory filingsServe as safety expert on Evidence Generation Team for assigned productsInspection ReadinessTravel: Domestic and International travel up to 10% may be essentialWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a proactive leader with these qualifications.Basic Qualifications:MD or DO degree from an accredited medical school OR PhD OR PharmDAND2 years of global safety experience in Oncology, Inflammation, Nephrology, Bone, Cardiovascular or NeurologyPreferred Skills:Clinical/medical research experienceProduct safety or clinical development in the biotech or pharmaceutical industryPrevious management and or mentoring experienceExperience in leading teams and or projectsExpertise in Signal Detection Strategy and/or Risk Management Strategy PlansPrevious experience in lead safety signal esculations with executive leadership and interactions with regulatory authorities.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 benefitsApply now for 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.careers.amgen.comJoin UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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 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 accommodation.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, Thousand Oaks , Global Safety Medical Director- Global Safety Officer US-Remote, Executive , Thousand Oaks, California

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