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.
Sr Associate IS Bus Sys Analyst Safety ART - Safety Reporting
Let’s do this. Let’s 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 RFP’s
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:
Master’s degree with 1 to 3 years of experience in software engineering, IT or related field
Or
Bachelor’s 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, we’ll 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.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.