Sr Associate IS Bus Sys Analyst Safety ART - Safety Reporting

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Associate IS Bus Sys Analyst Safety ART - Safety Reporting

Lets do this. Lets change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of Pharmacovigilance (PV) platforms and supporting technologies. In this role, you will be responsible for reporting and analytics solutions to help drive strategic business outcome. This role focuses on delivering data-driven solutions, automating processes, and addresses the ongoing issues and improving adverse event management cycle-time from source to target systems.

• Collaborate with business users, data owners, and product owners to identify and prioritize system improvements and new functionalities to meet evolving PV business needs
• Provide guidance and set standards in producing quality documentation, serving as liaison between IS and PV Business
• Support the day-to-day operations and maintenance of PV systems
• Support technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems (IS) Change Control and GxP validation process
• Responsible for authoring computer validation documents
• Leads and contributes to business case development, workshops, and RFPs
• Engage with key vendors and platform owners to understand functionality and how those platforms can be used to solve compliance or business problems
• Keeps updated on industry trends, emerging trends and standard processes for PV systems

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Masters degree with 1 to 3 years of experience in software engineering, IT or related field

Or

• Bachelors degree with 4 to 5 years of experience in software engineering, IT or related field

Or

• Diploma with 7 to 9 years of experience in software engineering, IT or related field

Preferred Qualifications:

• Experience in health and/or life sciences and Information Technology as a Business Analyst supporting SaaS Applications
• Excellent written, verbal communication and presentation skills with outstanding ability to explain technical concepts to non-technical users
• Experience documenting business requirements
• Experienced in data analysis and reporting using analytics tools such as Tableau, Power BI
• Experienced in Agile project methodologies
• Experience in Systems Development Life Cycle (SDLC), including requirements gathering, design, data analysis, testing, and change control

• Experienced in relational database (e.g. Oracle, PostgreSQL) and writing SQL
• Knowledge of one or more general programming languages, including but not limited to: Java or Python
• Knowledge of API integrations such as MuleSoft & Databricks
• Experience working in cloud services such as AWS
• Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11 and GxP Compliance
• Knowledgeable of new technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG)

• SAFe for Teams certification (preferred)

• Excellent analytical and problem-solving skills with a good attention to detail
• Ability to deal with ambiguity and work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to influence and hold team members accountable to commitments

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.

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. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.