Specialist IS Bus Sys Analyst - Signal & Risk Management

hnologies. This role focuses on delivering data-driven solutions, automating processes, and addresses the ongoing issues with Signal and Risk management systems.

Roles & Responsibilities:

• Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs

• Responsible for defining and implementing a project and technical road maps that align with the strategy

• 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

• Work closely with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines

• Identify data patterns to support informed decision making. Collect analyze, and interpret data to identify trends, insights, and areas of improvement.

• Keeps updated on industry trends, emerging trends and standard processes for pharmacovigilance systems

• Leads and contributes to business case development, workshops, and RFP's

• 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:

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

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

• 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

• Strong communications skills in writing, speaking, communicating and time management skills

• Has high learning agility, problem solving and analytical thinking

• Has requirements gathering and process improvement experience

Good-to-Have Skills:

• Ability to work in a fast-paced and dynamic environment

• Able to communicate technical or complex subject matters in business terms

• Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients

• Experience with Safety Signal and Risk Management platforms is a plus

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

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.

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