Our client is looking for a contract Senior Business Analyst who is an expert in ICH GCP and E2B R3 or who can learn this very quickly.

If you understand that abbreviation, please let me know and give me a call.

They have an interim role as an expert Business Analyst who can support the transition from E2B R2 to E2B R3. You will also need to have a strong understanding of.XML

The client is fast growing and was founded by Pharma industry experts that specialise in providing data quality and data capture analysis to Pharmaceutical companies. Their development of a web-based application allows them to work within the fields of technology, research and the life science sector. You should ideally have a background in web-based SaaS applications.

They simplify adverse event reporting and product quality data capture and improve analysis. They have developed a solution that transforms the end-to-end pharmacovigilance process offering immediate benefits; efficiency and effectiveness in process automation; simple and rapid access to data; accelerate early detection of safety or quality issues.

Snapshot of what you will be doing:

• To be the subject matter expert on the E2B R3 regulatory update fort he team
• Work with the teams and developers to determine the requirements to implement the data migration
• Create and refine documentation which includes user requirements, conceptual data models, process flows and UI mock-ups. This includes. XML schemas
• Participate in requirements reviews, test planning, documentation reviews and application validations with SMEs
• Training the Product and Software development team on the technical requirements of this data migration
• Educating client facing teams on the regulatory change and how to respond to client question on this
• Author Validation Plans, Validation Summaries, Deviations and Notes to File
• Interface directly with Engineering, SQA, Regulatory and Technical Communication to ensure the expected functionality is understood and documentation is accurate
• Handle the day-to-day issues relating to a product release
• Answer inquiries regarding product functionality after a release and process enhancement

Required Experience:

• defined business-based test scenarios for data migration/integrations
• Good understanding and ideally expert skills in XML like schemas and standards.
• Business Analyst experience as Product Owner or desire to be
• Adverse Event reporting experience, Drug Safety, Pharmacovigilance
• Complex SaaS enterprise solutions
• Cross-product platform solutions for large product suites, and/or product integration/unification initiatives
• Working with Agile development teams to successfully deliver enterprise software products
• Strong understanding of clinical trials and the regulations of trials. ICH-GCP HL7 ICH GCP and E2B R3
• Passion for creating customer value through innovative technology solutions
• Entrepreneurial, and action-oriented
• Immaculate presentation verbal and written communication skills
• Superior analytical, problem-solving, quantitative, and critical thinking abilities
• Experience with turning data into valuable information and knowledge
• Defining functionality and managing a story backlog using the Agile methodology and tools
• Life sciences / clinical trial technology experience
• Bachelor of Science degree
• YOU SHOULD ALREADY BE ELIGIBLE TO LIVE AND WORK IN THE UK.

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