Amgen
Global Safety Officer (GSO), Global Safety Medical Director - Cardiovascular, US
Amgen, Phila, Pennsylvania, United States
Overview
Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote Join Amgen’s mission to serve patients living with serious illnesses. Since 1980, Amgen has helped pioneer biotech in four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease. As a member of the Amgen team, you’ll help make a lasting impact on patients as we research, manufacture, and deliver innovative medicines. Our award‑winning culture is collaborative, innovative, and science based. If you thrive on challenges and opportunities, you’ll grow with Amgen while transforming lives and your career. What you will do
In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for assigned development product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. You will be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will lead the Safety Analysis Team (SAT) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). You will participate as a member of the Evidence Generation Team and other cross‑functional teams and may be assigned as delegate for the Therapeutic Area Head (TAH) with management of Global Safety Physicians.
Validate safety signals and lead safety signal assessments Develop 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 measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Prepare/review safety sections of new drug applications and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness Travel: Domestic and International travel ~10% may be required What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Medical Safety professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications: Industry pharmacovigilance (PV) experience Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Board certification or equivalent training Expertise in Obesity therapeutic area Leadership experience within the safety profile of products assigned with cross-functional team members What you can expect from us
As we work to develop treatments that care for 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 $243,245 to $319,267. Actual salary will vary based on relevant skills, experience, and qualifications. In addition to base salary, Amgen offers a Total Rewards Plan with eligibility for health and welfare plans, retirement savings, work/life balance, and career development opportunities, including: A comprehensive benefits package with group medical, dental, vision, life and disability insurance A discretionary annual bonus program (or field sales incentive plan where applicable) Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid options where possible Apply now and make a lasting impact with Amgen. careers.amgen.com In 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. Application deadline 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. #obesity 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. Salary Range: 243,245.00 USD - 319,267.00 USD
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Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote Join Amgen’s mission to serve patients living with serious illnesses. Since 1980, Amgen has helped pioneer biotech in four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease. As a member of the Amgen team, you’ll help make a lasting impact on patients as we research, manufacture, and deliver innovative medicines. Our award‑winning culture is collaborative, innovative, and science based. If you thrive on challenges and opportunities, you’ll grow with Amgen while transforming lives and your career. What you will do
In this vital role within the Global Patient Safety (GPS) organization, you will serve as the safety expert for assigned development product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. You will be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will lead the Safety Analysis Team (SAT) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). You will participate as a member of the Evidence Generation Team and other cross‑functional teams and may be assigned as delegate for the Therapeutic Area Head (TAH) with management of Global Safety Physicians.
Validate safety signals and lead safety signal assessments Develop 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 measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Prepare/review safety sections of new drug applications and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness Travel: Domestic and International travel ~10% may be required What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Medical Safety professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications: Industry pharmacovigilance (PV) experience Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Board certification or equivalent training Expertise in Obesity therapeutic area Leadership experience within the safety profile of products assigned with cross-functional team members What you can expect from us
As we work to develop treatments that care for 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 $243,245 to $319,267. Actual salary will vary based on relevant skills, experience, and qualifications. In addition to base salary, Amgen offers a Total Rewards Plan with eligibility for health and welfare plans, retirement savings, work/life balance, and career development opportunities, including: A comprehensive benefits package with group medical, dental, vision, life and disability insurance A discretionary annual bonus program (or field sales incentive plan where applicable) Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid options where possible Apply now and make a lasting impact with Amgen. careers.amgen.com In 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. Application deadline 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. #obesity 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. Salary Range: 243,245.00 USD - 319,267.00 USD
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