Global Safety Physician, Senior Medical Scientist- Rare Disease

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.
Global Safety Physician, Senior Medical Scientist- Rare Disease What you will do Let's do this.
Let's change the world.
In this vital role, you will serve as the medical expert of the team to support the Global Safety Officer (GSO) in the conduct of quality safety assessment and risk management processes and activities for an assigned set of products through the products' life cycle.
The Global Safety Physician (GSP) is responsible for the conduct of safety monitoring and is accountable for executing all product-related safety decisions and deliverables for assigned products as designated by leadership.
The Global Safety Physician is responsible for the following:

Advises the planning, preparation, writing, and review of portions of aggregate reports
Review and provide input and support on study protocols, statistical analysis plans, and other clinical study-related documents
Review of AEs/SAEs from clinical trials as needed
Review standard design of tables, figures, and listings for safety data from clinical studies
Participate in development of safety-related data collection forms for clinical studies
Participate in study team meetings
Perform data analysis to evaluate safety signals and write up analysis results
Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body
Provides contents for risk management plans
Develop or update strategy and content for regional risk management plans
Assist GSOs to coordinate risk minimization activities including tracking of activities as needed
Evaluate risk minimization activity
Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
Assist GSO in developing a strategy for safety-related regulatory activities
Provide safety contents for filings
What we expect of you We are all different, yet we all use our unique contributions to serve patients.
The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of relative experience
OR
Masters degree and 4 years of relative experience
Bachelors degree and 6 years of relative experience
Associates degree and 10 years of relative experience
High school diploma / GED and 12 years of relative experience
Preferred Qualifications:
MD, DO, or equivalent degree from an accredited medical school plus 2 years of directly related experience
MD from a foreign medical school
Clinical/medical research experience
Product safety in the bio/pharmaceutical industry
Previous management and/or mentoring experience
Experience in leading teams and/or projects
What you can expect of us As 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:

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
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
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.
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.
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