Job Description

Career Category Information Systems

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.
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
Specialist Software Engineer - Safety ART - Safety Reporting
What you will do
In this technical role, you will be responsible for designing, implementing, and maintaining technological solutions that support pharmacovigilance (PV) reporting & analytics solutions. This role bridges the gap between safety operations and information systems, ensuring data integrity, regulatory adherence, and efficient reporting through advanced systems and tools.
Roles & Responsibilities:

• Maintain PV systems and provide production support as a System Owner.
• Support ETL (Extract, Transform, Load) pipelines to transfer PV/Safety data into a data lake for reporting and analytics.
• Monitor system performance, identify and resolve technical challenges effectively.
• Participate in Agile development ceremonies and practices.
• Conduct code reviews to ensure code quality and consistency to standards.
• Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations.
• Stay informed about industry developments, emerging trends, and standard practices relevant to systems and processes.
• Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs of drug-systems.
• Find opportunities for automation and process improvements within the drug-safety ecosystem.
• Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems Change Control and GxP validation process.
• Collaborate with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines.
• Maintain knowledge of market trends and developments in web application development frameworks and related and new technologies to provide, recommend, and deliver standard methodology solutions.
• Responsible for supporting technical root cause analysis and work with software vendors to resolve Pharmacovigilance systems related issues.

What we expect of you

• We are all different, yet we all use our unique contributions to serve patients.
• Master's degree with 4 to 6 years of experience in Computer Science, software development or related field
• Bachelor's degree with 6 to 8 years of experience in Computer Science, software development or related field
• Diploma with 10 to 12 years of experience in Computer Science, software development or related field

Must-Have Skills:

• At least five years of experience as a system owner for PV systems
• 3+ years of experience COTS Pharmacovigilance Platforms including Argus and/or ArisGlobal LSMV is a plus or other safety database.
• Proficient with at least one development programming language/technologies such as Database SQL and Python
• Experience with Business Intelligence tool such as Cognos, Tableau or Spotfire, with a preference for Cognos
• Must have a good understanding / experience of integration technologies
• Must have a strong understanding of the principles and experience of Database design, Data Warehouse using Fact Tables, Dimension Tables, Star and Snowflake schema.
• Solid understanding of Mulesoft and ETL technologies (e.g. Informatica, DataBricks)
• Familiarity with automation technologies UiPath and a desire to learn and support
• Understanding of AWS/cloud storage, hosting, and compute environments is required
• Experience in Software Development Life Cycle (SDLC), including requirements, design, data analysis, testing, and change control

Good-to-Have Skills:

• Experienced in managing GxP systems and implementing GxP projects
• Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11, GxP Compliance
• Sharp learning agility, problem solving and analytical thinking

Professional Certifications:

• Understanding and experience with Agile methodology and DevOps OR
• Agie Software Engineer certification (preferred)

Soft Skills:

• Ability to work on multiple projects simultaneously
• Expertise in visualizing and manipulating large data sets
• Willing to learn to new technologies
• High learning agility, innovation, and analytical skills
• Strong communication and presentation skills

Shift Information:

• This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

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.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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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Skills Required