Manager Information Systems - ICSR Processing - ICMA

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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.

• Partner with IS and Business collaborators to understand how automation can improve workflow and efficiency; ensuring solutions meet business needs.
• Lead the day-to-day operations and maintenance of Pharmacovigilance systems (safety database).
• Find other 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.

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

Basic Qualifications:

• Masters degree with 4 - 6 years of experience in Computer Science, IT or related field OR
• Bachelors 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 passion for tackling complex challenges.
• Collaborative spirit and effective communication skills to work seamlessly in a multi-functional team.
• An ongoing commitment to learning and staying at the forefront of AI/ML advancements.
• Experienced in AI/ML technologies 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 .

• 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 troubleshooting 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.