Manager Information Systems - ICSR Processing

 

What you will do 
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 safety platforms and supporting technologies. In this role, you will engage with business users and functional SMEs, driving the delivery of innovative technology solutions that enhance business outcomes. Areas of focus will be on leading team performance, delivery management, mentorship, and facilitating continuous improvement in both technical skills and user experience. This is a first-level management role that requires hands-on leadership to develop your team’s capabilities while aligning with business needs and strategic goals.



 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

Part of project/product team, willing to jump in and do programming/code-reviews etc. based on demands. Hands on programming (SQL/Scripts) is expected.

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

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 
We are all different, yet we all use our unique contributions to serve patients.





Basic Qualifications:

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

Excellent problem-solving skills and a commitment to resolving challenges

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

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

5 + years of experience COTS Pharmacovigilance Platforms (for example Argus) is a plus or other safety database

2+ years of management or leadership experience or leadership of or leading a team of technical experts

 

Preferred Qualifications: 

Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL

Experience with API integrations such as MuleSoft

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

Experienced in managing GxP systems and implementing GxP projects

Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control

Professional Certifications:

SAFe for Teams certification (preferred)

SAFe Product Owner and SAFe Product Manager (preferred)

Soft Skills:

Excellent analytical and fix skills

Excellent leadership and critical 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.



 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.



 

Apply now for a career that defies imagination 
Objects in your future are closer than they appear. Join us.

 

careers.amgen.com 


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.