Specialist IS Bus Sys Analyst Safety ART - E2E Reconciliation

What you will do
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.

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 RFPs

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

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

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

Certification:

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.