Senior Manager IT – Safety ART

Career Category

Job Description

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 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.

Senior Manager IT – Safety ART

What you will do

Let’s do this. Let’s change the world. In this vital role you will become an influential strategic IT partner within the Global Patient Safety (GPS) organization. This role is accountable for end-end-end service delivery, encompassing strategy formulation to execution, with a strong emphasis on redefining the Safety IT technology landscape.

As we stride towards the future, this role will be pivotal in advancing the next generation of Safety platforms and supporting technologies. We seek a candidate who brings a blend of Pharmacovigilance (PV) domain expertise and technical competence in safety and associated technologies. Your contribution will not just be about leading existing systems, but about innovating and steering the technological evolution in patient safety.

If you're ready to take on this challenge and shape the future of Safety IT, we invite you to be part of our journey.

• Take a leadership role in the management of the product team and CW’s by educating, motivating, and guiding in delivery and maintenance of this service delivery to enrich business area strategy.

• Lead all aspects of the international components of the Safety systems landscape, facilitating adverse event (AE) Intake & Expedited Reporting, Medical Coding, Terminology Management, and both Periodic and Operational Reporting for Safety and Risk Assessment.

• Engage with Amgen’s International and US based Patient Safety business organization.

• Serve as the primary liaison for international Safety Executive management and as well as Qualified Person Responsible for Pharmacovigilance (QPPV)

• Lead conversations with architects, vendors, and other partners to build and maintain solutions in the Safety area.

• Participate as a domain subject matter expert (SME) for end-to-end Pharmacovigilance systems.

• Define and advance the product roadmap by collaborating with the product manager, customers, and product team for Pharmacovigilance Operations

• Champion innovation to elevate Amgen's Safety systems, empowering the business to improve its processes, efficiency, and effectiveness. This involves integrating cognitive capabilities to thoughtfully automate traditional, manual processes.

• Promote the adoption of global technology capabilities and standards to address complex business challenges.

• Learning Champion for AI technologies and keeps up to date on new industry and emerging technologies in the Pharmacovigilance area

• Responsible for portfolio and financial management including securing funds, RFPs, exploration of solution options, forecasting, demand/resource planning, vendor management and run/build operations for reporting

• Oversee, mentors, and lead a dedicated team comprised of business analysts, software analysts, and testers

• Improve procedures associated with Maintenance and Support

• Responsible for audit and inspection activities

What we expect of you

Basic Qualifications:

• Doctorate degree and 2 years of Information Systems experience OR,

• Master’s degree & 8 to 10 years of Information Systems experience OR,

• Bachelor’s degree and 10 to 14 years of Information Systems experience OR,

• Diploma and 14 to 18 years of Information Systems experience

• Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with data

• Collaborative spirit and effective communication skills to work seamlessly in a cross-functional team

• An ongoing commitment to learning and staying at the forefront of AI/ML advancements.

Preferred Qualifications:

• Degree Educated in relevant field

• Proven experience in working within IT Industry work experience in Analysis, Design, Development, Testing and Maintenance of software applications in Health & Life Sciences

• Strong preference supporting Global Patient Safety

• Experience of working on and leading major programs/projects that involve multiple partners and external vendors and leading end-to-end from initiation to project closure

• Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements

• Strong communications skills in writing, speaking, making pitches to various audiences in a clear and concise manner

• Experience in database programming and knowledge of concepts in SQL (e.g. Oracle)

• Knowledgeable with cloud computing technologies (e.g. AWS) and integration technologies (e.g. Mulesoft).

• Experience in DevOps, and Scaled Agile Framework (SAFe), especially in regulated setting including ability to lead the transformation of teams from a service based to a product-based model

• Experience with Quality Control and Quality Assurance processes and systems

• Demonstrable experience in group facilitation – ability to guide teams to make decisions and achieve results within agreed parameters & timescales

• Experience in Case Management process

• Prior experience as a people manager, a program/ project team lead or mentor of team

• In-depth experience in all aspects of SDLC from requirements, design, testing, data analysis and Change Control process combined with experience developing project charters, statement of work and project financials

Good-to-Have Skills:

• Demonstrated expertise in a scientific domain area and related technology needs

• Understanding of scientific data strategy, data governance, data infrastructure

• Experience with cloud (e.g. AWS) and on-premise compute infrastructure

• Experience with stakeholder management, managing a team of 20, ensuring seamless coordination across teams and driving the successful delivery of technical projects

• Familiarity with data analytics and scientific computing platforms such as Databricks, Dash, Plotly, Spotfire and related programming languages like SQL, python

• Experience creating impactful slide decks and communicating data

• Ability to drive projects/company initiatives using Agile methodology

• We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.

Professional Certifications:

• SAFe for Teams certification (preferred)

• SAFe Product Owner and SAFe Product Manager (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

Work Hours: 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. Potential Shifts (subject to change based on business requirements): Second Shift: 2:00pm – 10:00pm IST; Third Shift: 10:00 pm – 7:00 am IST.

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.