Data Analytics Specialist – Integrated Signal Management

remote type

Remote

locations

United States – Remote

time type

Full time

job requisition id

R-181429

Career Category

Information Systems

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Data Analytics Specialist- Integrated Signal Management

Live

What you will do

Lets do this. Lets change the world. In this vital role you will provide direction and strategy for the product safety signal detection and support to quality complaints trending program. You will prepare product complaints or adverse event data to support ad-hoc analysis and regulatory inquiries, as well as generate process metrics to support process surveillance activities.

Key Activities:

• Prepare and interpret adverse events and product complaints data supporting integrated product surveillance activities
• Prepare product and process surveillance metrics for internal safety and quality governance forums
• Prepare complaints and/or adverse event data to support ad-hoc analysis and/or regulatory inquiries
• Apply analytical skills to evaluate complex situations using multiple sources of information
• Interpret SOP requirements

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Data Analytics Specialist professional we seek has these qualifications:

• Knowledge of product complaints and adverse events handling process
• Ability to pull and create product complaints data per request
• Quality and manufacturing experience in biotech or pharmaceutical industry

Basic Qualifications:

Doctorate degree

Or

Masters degree & 2 years of Quality / Manufacturing experience

Or

Bachelors degree & 4 years of Quality / Manufacturing experience

Or

Associates degree & 10 years of Quality / Manufacturing experience

Or

High school diploma / GED & 12 years of Quality / Manufacturing experience

Preferred Qualifications:

• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelors Degree in a Science Field
• Ability to oversee multiple projects simultaneously
• Ability to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging and Device manufacturing processes)

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.

careers.amgen.com

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.

Salary Range

113,553.00 USD – 141,032.00 USD