Specialist IS Bus Sys Analyst – Safety Reporting

Career Category

Job Description

Specialist IS Bus Sys Analyst – Safety Reporting

Department Name: Digital, Technology & Innovation

ABOUT AMGEN

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.

ABOUT THE ROLE

Role Description:

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.

Roles & Responsibilities:

• 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

Basic Qualifications and Experience:

• 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

Professional Certifications:

• 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.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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 an accommodation.