<h2>Career Category</h2>Safety<h2></h2><h2>Job Description</h2>Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Director Global SafetyWhat you will do and what we expect of youLet’s do this. Let’s change the world. In this vital role you will:  Duties: Accountable for working with Product Teams to develop strategy for signal assessment activities; Accountable for staff management of Global PV Scientists (GPvS) and resource planning including strategy development; Provide scientific and compliance expertise as needed to GPvS, and expert advice to GPvS; Direct the planning, preparation, writing and review of aggregate reports; Provide oversight to staff with regards to safety in clinical trials including review of SAEs/AEs; Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents; Review standard design of tables, figures, listings for safety data from clinical trials, and development of collection forms; Participate and contribute to study team meetings; Provide expertise to product teams in strategy for responding to questions (RTQs); Collaborate and decision making with department heads to implement new and revised processes and pharmacovigilance standards across the divisions/groups; Support product team in performing data analysis to evaluate safety observations, and review write up of analysis results. May telecommute. Supervises direct reports. Requirements: Master’s degree (or foreign equivalent) in Pharmaceutical Science or related field and 2 years of experience in the following: 1. Processes and regulations for pharmacovigilance and risk management such as aggregate data analysis, understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice, creation and maintenance of risk management plans;2.   Drug development life cycle (Phase 1, 2, 3 and post-market);3.   Safety data capture in clinical development and post-market settings;4.   Medical Dictionary for Regulatory Activities (MedDRA), Common Terminology Criteria for Adverse Events, and WHODrug; 5.  Developing search strategies using MedDRA terminology to investigate the safety database for evaluation of safety signals from clinical studies, post-market, solicited and literature sources;6.   Pharmacovigilance skills such as interpretation of data and ability to convey scientific data to stakeholders, application of statistical and epidemiological methods, and critical scientific assessment; 7.  Analyzing, employing, and investigating scientific and medical data in verbal and written format;8.   Utilizing software-based drug safety systems such as Argus and Rave; and 9.  Researching with scientific literature databases such as Biological Abstracts (BIOSIS), Excerpta Medical Database (Embase), and Ovid interface.  Contact: Interested candidates please apply via <a href="https://careers.amgen.com/en/search-jobs" target="_blank">https://careers.amgen.com/en/search-jobs</a> and search for job #  R-223005. Job type: Full Time position. The annual salary range for this position in the U.S. is $202,583.00 - $241,880.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit <a href="https://urldefense.proofpoint.com/v2/url?u=https-3A__nam11.safelinks.protection.outlook.com_-3Furl-3Dhttps-253A-252F-252Furldefense.proofpoint.com-252Fv2-252Furl-253Fu-253Dhttps-2D3A-5F-5Fnam11.safelinks.protection.outlook.com-5F-2D3Furl-2D3Dhttps-2D253A-2D252F-2D252Furldefense.proofpoint.com-2D252Fv2-2D252Furl-2D253Fu-2D253Dhttps-2D2D3A-2D5F-2D5Fnam11.safelinks.protection.outlook.com-2D5F-2D2D3Furl-2D2D3Dhttps-2D2D253A-2D2D252F-2D2D252Furldefense.proofpoint.com-2D2D252Fv2-2D2D252Furl-2D2D253Fu-2D2D253Dhttps-2D2D2D3A-2D2D5F-2D2D5Fnam11.safelinks.protection.outlook.com-2D2D5F-2D2D2D3Furl-2D2D2D3Dhttps-2D2D2D253A-2D2D2D252F-2D2D2D252Furldefense.proofpoint.com-2D2D2D252Fv2-2D2D2D252Furl-2D2D2D253Fu-2D2D2D253Dhttps-2D2D2D2D3A-2D2D2D5F-2D2D2D5Fcareers.amgen.com-2D2D2D5Flife-2D2D2D2D2Dat-2D2D2D2D2Damgen-2D2D2D5Fbenefits-2D2D2D5F-2D2D2D2526d-2D2D2D253DDwMGaQ-2D2D2D2526c-2D2D2D253D6HFirGB4LnuU4asVt8kNcMhC5SvBtxbjoaC4-2D2D2D2DrMbhtk-2D2D2D2526r-2D2D2D253DZzsBV9k-2D2D2D2DjttVNN1EvZst0Q-2D2D2D2526m-2D2D2D253DbXelMAn-2D2D2D2DLkr6ITgl-2D2D2D2DOVIwCkmHKYirp3gc83wvPae1SgtYIJYqwI2avmaKPLstizO-2D2D2D2526s-2D2D2D253DkeznBgK-2D2D2D2DF4tRtUWSI5ABybrJF1hszDEySq52Jge-2D2D2D2D2Mk-2D2D2D2526e-2D2D2D253D-2D2D2D26data-2D2D2D3D05-2D2D2D257C01-2D2D2D257Cjen01-2D2D2D2540amgen.com-2D2D2D257C660a28539c1044de1e4108db272cafda-2D2D2D257C4b4266a6136841afad5a59eb634f7ad8-2D2D2D257C0-2D2D2D257C0-2D2D2D257C638146845207554495-2D2D2D257CUnknown-2D2D2D257CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0-2D2D2D253D-2D2D2D257C3000-2D2D2D257C-2D2D2D257C-2D2D2D257C-2D2D2D26sdata-2D2D2D3DcYzBM3rFPl6qL6wF1v5QiaiQBXGj4x6xspFO9HqU9Vg-2D2D2D253D-2D2D2D26reserved-2D2D2D3D0-2D2D2526d-2D2D253DDwMGaQ-2D2D2526c-2D2D253D6HFirGB4LnuU4asVt8kNcMhC5SvBtxbjoaC4-2D2D2DrMbhtk-2D2D2526r-2D2D253DZzsBV9k-2D2D2DjttVNN1EvZst0Q-2D2D2526m-2D2D253DUnLMPhr-2D2D2DEGnpr9XBuHlwWv-2D2D2Dn4T7T8VuRZFDjwpT9dOvwdZKz7drSop9P1WDp591w-2D2D2526s-2D2D253Dc0sqSn-2D2D2DN3CobCiFz89Y-2D2D2Ds8tVcO-2D2D2D8OnDdCGlXU0NbgBc-2D2D2526e-2D2D253D-2D2D26data-2D2D3D05-2D2D257C01-2D2D257Crodneyj-2D2D2540amgen.com-2D2D257" target="_blank">https://careers.amgen.com/life-at-amgen/benefits/</a>  What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:<ul><li>A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts</li><li>A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</li><li>Stock-based long-term incentives</li><li>Award-winning time-off plans</li><li>Flexible work models, including remote and hybrid work arrangements, where possible</li></ul>Apply now and make a lasting impact with the Amgen team. careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.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 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..