Specialist Is Business Analyst - Adverse Event Receipt Management (Us Remote)

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist Business Analyst - Adverse Event Receipt Management

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will deliver innovative custom solutions for supporting patient safety and adhering to regulatory requirements from around the world for adverse events. This involves systems related activities to support the Global Patient Safety organization in the lifecycle of individual case safety report (ICSR) and daily operational oversight of the data with the PV systems/integrations ecosystem. You will be an active participant in the team directly working towards advancing technical features and enhancements of the business applications, in the next generation of Safety platform and supporting technologies.

• Responsible for defining and implementing a project and technical road maps that align with the strategy
• Leads and contributes to business case development, workshops, and RFP’s
• Partner with IS and Business stakeholders to analyze and understand business needs by improving and addressing process gaps and enabling automation
• Manage MSP teams ensuring operational excellence, continuous improvements, and adherence to Amgen’s ITIL processes
• Supports PV audits/inspections
• Analyze and explore industry trends and standard methodologies for innovative solutions for Global Patient Safety (GPS)
• Responsible for mentoring the product teams
• Responsible for authoring validation artifacts such as requirements, design, and architectural specifications
• Responsible for supporting and leading technical root cause analysis and working with product teams/vendors to resolve PV systems related issues
• Ensure that the applications are aligned with approved architectural and development guidelines
• Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The analyst we seek will have these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of relevant experience

Or

Bachelor’s degree and 5 years of relevant experience

Or

Associate’s degree and 10 years of relevant experience

Or

High school diploma / GED and 12 years of relevant experience

Preferred Qualifications:

• Knowledgeable of Agile project methodologies and working in Product Teams by using JIRA
• Some working knowledge of SQL skills set preferred (e.g. Oracle)
• Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11, GxP Compliance, and change control
• 5 years of experience in health and/or life sciences and Information Technology as a Business Analyst
• Strong communications skills in writing, speaking, communicating and time management skills
• Working experience in cloud services such as AWS
• Knowledgeable of new technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG)
• Has high learning agility, problem solving and analytical thinking

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.

The annual base salary range for this opportunity in the U.S. is $101,300-127,167 USD.

In addition to the base salary, 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:

• Award-winning time-off plans and bi-annual company-wide shutdowns
• 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
• Flexible work models, including remote work arrangements, where possible
• Stock-based long-term incentives

Apply now

for a career that defies imagination

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

careers.amgen.com

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.