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 innovati

What you will do

• 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

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

Good-to-Have Skills

• Must have a good understanding / experience of integration technologies