Global Safety Manager

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 Manager

What you will do

Let's do this. Let's change the world. In this vital role you will join a team of PV Scientists working in collaboration with Global Safety Officers (GSO) to provide the safety strategy and major safety deliverables for Amgen product. The Immuno-oncology team has an exciting portfolio of products ranging from Early Development through the Post marketing settings. We need collaborative and innovative world-class talent to ensure these molecules and medicines reach their full potential while helping patients.

Responsibilities

Contributes to the planning, preparation, writing and review of periodic aggregate safety reports.

Works with affiliates and other internal Amgen partners regarding deliverables.

Review of adverse events and serious adverse events from clinical trials.

Contributes under the direction of the Global PV Sr. Scientist or Lead

Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents

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

Attend study team meetings as requested or needed

Conduct signal detection, evaluation, and management

Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO

Prepare safety assessment reports and other safety documents and regulatory responses

Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection

Participates in Safety Governance per Amgen processes

Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body

Assist GSOs and other Senior Scientists in the development of risk management strategy and activities

Provides contents for risk management plans

Update strategy and content for regional risk management plans

Assist GSOs to oversee 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

Support activities related to new drug applications and other regulatory filings

Assist GSO / or other Senior Scientist in developing a strategy for safety-related regulatory activities

Provide safety contents for filings

Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by the supervisor

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 scientist with these qualifications.

Basic Qualifications :

Doctorate degree OR

Master's degree and 2 years of relevant experience OR

Bachelor's degree and 4 years of relevant experience

Preferred Qualifications :

Healthcare professional background

1 year of drug safety / PV experience

Experience in signal detection, evaluation and management

Experience as a contributor to periodic aggregate safety reports

Experience with literature surveillance : source document review, knowledge, and skills

Experience with the Argus Safety database

Good clinical and scientific judgment

Clinical and / or medical research experience

Strong written and verbal communication skills

What you can expect from 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

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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. 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.