Acceptance Testing, Analysis Skills, Artificial Intelligence (AI), Biology, Biotech and Pharmaceutical, Business Analysis, Business Processes, EAD, GxP, Maintain Compliance, Pharmaceutical Analysis, Pharmacovigilance, Presentation/Verbal Skills, Regulatory Compliance, Standard Operating Procedures (SOP), Standards Development, System Validation, Test Data, Test Scripts, Testing
Role: Lead Business Analyst with Pharma, GxP Experience
Location: Raleigh NC or Foster City, CA
Duration: Contract (W2)
VISA Type: USC / GC / GC EAD Only
Mandatory Skills: Business Analyst, Pharma GxP, Pharmacovigilance domain Experience
Job Description:
- 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.