Global Safety Senior Manager

Title: Global Safety Senior Manager

US Remote

Location: DC-Washington

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Safety Senior Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of the Combination Product Global Safety Team within the Combination Products Safety group ensuring the excellence of Amgen products for the portfolio.

Responsibilities

• Assessing potential impact of quality findings on patient user safety for all clinical and commercial products in conjunction with members of the Global Safety Team
• Providing consultation to Therapeutic Area Safety for the review of adverse event data to detect potential product quality issues for commercial products
• Providing consultation for device combination product diagnostic safety data collection, analysis, and reporting
• Provide expertise for device combination product risk management activities
• Contribute to assigned product Safety Advisory Team/ Global Safety Team pharmacovigilance activities when they pertain to device, companion diagnostic and digital health safety, including single case assessment, aggregate data analysis, and risk management activities.
• Provide combination product safety expertise to protocol, ICF, CSR review and preparation of filing documents.
• Support responses to regulatory queries for safety information as required.
• Conduct review of adverse event aggregate data to detect potential product/device quality issues.
• For assigned products, provide review of and input to device risk management documents, including hazard analysis, use risk assessments, human factors protocols and reports, etc.
• Perform authoring of device combination product system risk/benefit analyses
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The safety professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree in Science and 2 years of safety experience

Or

Master’s degree in Science and 6 years of safety experience

Or

Bachelor’s degree in Science and 8 years of safety experience

Or

Associate’s degree in Science and 10 years of safety experience

Or

High school diploma / GED and 12 years of safety experience

Preferred Qualifications:

• Relevant scientific training OR clinical experience in activities relevant to utilization of medical devices and/or companion diagnostics.
• Previous experience creating Medical Opinion Memos, Health Hazard Assessments, or Medical Inputs for product complaints.
• Solid understanding of clinical trial device safety monitoring regulations and standards
• Strong knowledge of device development and commercialization principles
• Knowledge of post market safety reporting regulations/standard methodologies for devices/combination products globally.
• Basic understanding of signal detection principles for drugs/biologics.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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.