Business Analyst - Pharmacovigilance
$143,520–$143,520 year
Remote · Cambridge, Massachusetts, United States
Job Summary
Principal IT Business Analyst in PV IT to elicit, analyze, validate, specify and document stakeholders’ functional and business needs for IT services and solutions. Responsible for gathering use cases and requirements, translating business needs into IT solutions, outlining business processes and data flow, analyzing options among tools, facilitating prioritization, and delivering SDLC artifacts (business/functional requirements, traceability matrices, etc.). Collaborates with stakeholders to define project vision/scope, conducts interviews/workshops, develops documents (SOW, objectives & metrics, use cases, storyboards, functional specs, end-user documentation), and supports trainings for application users and IT support teams.
Required Qualifications
- Undergraduate degree or the equivalent combination of education and experience required
- 5 – 7 years of experience in business process analysis in pharmaceutical environment focused on development sciences domain
- Experience with pharmacovigilance solutions in life sciences companies and knowledge of regulatory guidance and compliance (GxP and 21 CFR Part 11 regulations)
- Experience with data migration
- Direct experience with systems such as Veeva Vault. Nice to have: Veeva Vault Safety
- CBAP or PMP certification is a plus
- Familiarity with system application architecture
- Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner
- Requirements Definition and Management
- User Experience Design & Analysis
- User Acceptance Testing (UAT)
Desired Qualifications
- CBAP or PMP certification is a plus
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