Proven experience working as a Business Analyst (BA) or Senior Business Analyst in Pharma GxP IT projects, preferably within the Pharmacovigilance domain.
Strong understanding of end-to-end business processes and their alignment with IT solutions.
Good awareness and understanding of Artificial Intelligence (AI), including relevant concepts, capabilities, and applications within the pharmaceutical and life sciences industry.
Ability to gather, analyze, and document business requirements and prepare comprehensive Business Requirements Documents (BRDs).
Experience in developing and maintaining Standard Operating Procedures (SOPs).
Collaborate effectively with Business, IT, and BPO teams throughout the solution lifecycle, including design and build phases.
Lead and coordinate User Acceptance Testing (UAT), including Test script preparation and review, Test data identification and preparation, Test execution support and result evaluation, Preparation and presentation of UAT summary reports
Partner with Validation teams to support system validation activities and ensure compliance with GxP requirements.
Excellent stakeholder management, communication, and analytical skills.
Numbers & Facts
Location
Raleigh, NC
Industry
Other/Not Classified
Company Size
100 to 499 employees
Skills
Acceptance Testingunmatched
Analysis Skillsunmatched
Artificial Intelligence (AI)unmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Business Analysisunmatched
Business Processesunmatched
GxPunmatched
Maintain Complianceunmatched
Pharmaceutical Analysisunmatched
Pharmacovigilanceunmatched
Presentation/Verbal Skillsunmatched
Regulatory Complianceunmatched
Standard Operating Procedures (SOP)unmatched
Standards Developmentunmatched
System Validationunmatched
Test Dataunmatched
Test Scriptsunmatched
Testingunmatched
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