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Specialist IS Bus Sys Analyst Safety ART - E2E Reconciliation
What you will do
As a Specialist IS Bus Sys Analyst, you will join a collaborative team implementing and supporting the next generation of safety 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.
Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs
Lead the day-to-day operations and maintenance of Pharmacovigilance systems (safety database)
Find opportunities for automation and process improvements within the Safety ecosystem
Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process
Responsible for authoring validation with approved architectural and development guidelines
Identify data patterns to support informed decision making
Perform hands-on programming (SQL/Scripting) and participates in code reviews
Work closely with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines
Keeps updated on industry trends, emerging trends and standard processes for pharmacovigilance systems
Responsible for integrating safety data in the data lake for reporting solutions
Leads and contributes to business case development, workshops, and RFP's
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 and leading technical root cause analysis and works with vendors to resolve Pharmacovigilance systems related issues
Responsible for improving performance by coaching, mentorship, and training to develop both technical and professional skills within the team
Support audits and inspections
What we expect of you
Master's degree with 4 - 6 years of experience in Computer Science, IT or related field (OR)
Bachelor's degree with 6 - 8 years of experience in Computer Science, IT or related field (OR)
Diploma with 10 - 12 years of experience in Computer Science, IT or related field
Must Have Skills:
5 years of experience in health and/or life sciences and Information Technology as a Business Analyst supporting Saas Applications
Working experience in cloud services such as AWS
Experienced in data analysis and reporting using analytics tools such as Tableau, Power BI
Knowledgeable of new technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG)
Experienced in Agile project methodologies and working in Product Teams by using JIRA Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11, GxP Compliance, and change control
Experienced in writing advanced SQL skills set preferred (e.g. Oracle)
Strong communications skills in writing, speaking, communicating and time management skills
Has high learning agility, problem solving and analytical thinking
Good to Have Skills:
Experience with API integrations such as MuleSoft & Databricks
Solid understanding of using one or more general programming languages, including but not limited to: Java or Python
Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients
Sharp learning agility, problem solving and analytical thinking
Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control
Certification:
SAFe for Teams certification (preferred)
Soft Skills:
Excellent analytical and troubleshooting skills
Excellent leadership and strategic thinking abilities
Strong verbal and written communication skills
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation
Ability to manage multiple priorities successfully
Team-oriented, with a focus on achieving team goals
Strong presentation and public speaking skills
Ability to deal with ambiguity and think on their feet
Ability to influence and drive to an intended outcome
Ability to hold team members accountable to commitments
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. 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.
Apply now
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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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