Specialist Software Engineer - Safety ART - Safety Reporting

What you will do

In this technical role, you will be responsible for designing, implementing, and maintaining technological solutions that support pharmacovigilance (PV) reporting & analytics solutions. This role bridges the gap between safety operations and information systems, ensuring data integrity, regulatory adherence, and efficient reporting through advanced systems and tools.

Roles & Responsibilities:

• Maintain PV systems and provide production support as a System Owner.
• Support ETL (Extract, Transform, Load) pipelines to transfer PV/Safety data into a data lake for reporting and analytics.
• Monitor system performance, identify and resolve technical challenges effectively.
• Participate in Agile development ceremonies and practices.
• Conduct code reviews to ensure code quality and consistency to standards.
• Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations.
• Stay informed about industry developments, emerging trends, and standard practices relevant to systems and processes.
• Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs of drug-systems.
• Find opportunities for automation and process improvements within the drug-safety ecosystem.
• Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow Information Systems Change Control and GxP validation process.
• Collaborate with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines.
• 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 technical root cause analysis and work with software vendors to resolve Pharmacovigilance systems related issues.

What we expect of you

• We are all different, yet we all use our unique contributions to serve patients.
• Masters degree with 4 to 6 years of experience in Computer Science, software development or related field
• Bachelors degree with 6 to 8 years of experience in Computer Science, software development or related field
• Diploma with 10 to 12 years of experience in Computer Science, software development or related field

Must-Have Skills:

• At least five years of experience as a system owner for PV systems
• 3+ years of experience COTS Pharmacovigilance Platforms including Argus and/or ArisGlobal LSMV is a plus or other safety database.
• Proficient with at least one development programming language/technologies such as Database SQL and Python
• Experience with Business Intelligence tool such as Cognos, Tableau or Spotfire, with a preference for Cognos
• Must have a good understanding / experience of integration technologies
• Must have a strong understanding of the principles and experience of Database design, Data Warehouse using Fact Tables, Dimension Tables, Star and Snowflake schema.
• Solid understanding of Mulesoft and ETL technologies (e.g. Informatica, DataBricks)
• Familiarity with automation technologies UiPath and a desire to learn and support
• Understanding of AWS/cloud storage, hosting, and compute environments is required
• Experience in Software Development Life Cycle (SDLC), including requirements, design, data analysis, testing, and change control

Good-to-Have Skills:

• Experienced in managing GxP systems and implementing GxP projects
• Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11, GxP Compliance
• Sharp learning agility, problem solving and analytical thinking

Professional Certifications:

• Understanding and experience with Agile methodology and DevOps OR
• Agie Software Engineer certification (preferred)

Soft Skills:

• Ability to work on multiple projects simultaneously
• Expertise in visualizing and manipulating large data sets
• Willing to learn to new technologies
• High learning agility, innovation, and analytical skills
• Strong communication and presentation skills

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.