Description
The Senior Business Analyst serves as a key bridge between Pharmacovigilance, Safety Operations, Quality, Compliance, and Technology teams to support the delivery and enhancement of global safety systems and business processes.
This role leads complex business analysis activities across PV technology initiatives, including regulatory compliance, system implementations, system enhancements, integrations, reporting, validation support, and continuous improvement programs. The Senior Business Analyst translates business needs into clear, scalable, and compliant technology requirements, while providing subject matter expertise on PV systems and Japan-specific regulatory expectations.
The role also provides guidance to less-experienced Business Analysts and collaborates closely with cross-functional stakeholders, technical teams, vendors, and validation partners.
Essential Functions
- Business Analysis & Solution Delivery
- Lead discovery, analysis, and documentation of complex business requirements across Pharmacovigilance, Drug Safety, and Regulatory functions.
- Formulate and define systems scope, objectives, business rules, functional requirements, user stories, process flows, and system specifications based on user needs and applicable business requirements.
- Collaborate with business stakeholders, quality teams, and technology teams to analyze business requirements, support solution design discussions, and ensure successful implementation of compliant and scalable PV technology solutions.
- Analyze business and user needs and translate them into practical system requirement specifications that can be used by development, configuration, testing, validation, and support teams.
- Evaluate existing procedures, system behavior, data flows, and operational constraints to solve complex business and technology problems.
- Support requirements prioritization, impact assessment, release planning, and implementation readiness for PV technology initiatives.
- PV Systems & Technical Expertise
- Provide expert business and systems analysis support for pharmacovigilance safety applications and related ecosystem integrations.
- Work at a senior technical level across multiple phases of systems analysis while considering business implications of technology decisions in the current and future PV environment.
- Support implementation, upgrade, integration, migration, reporting, and enhancement initiatives for safety platforms.
- Use Oracle SQL capabilities to support data analysis, issue investigation, report validation, and requirements clarification.
- Partner with development, testing, validation, and production support teams throughout the SDLC.
- Compliance & Validation
- Ensure solutions comply with applicable GxP requirements and PMDA pharmacovigilance regulations, including Japan-specific safety reporting requirements and E2B standards.
- Experience supporting FDA, EMA, ICH, and other global pharmacovigilance regulations is highly desirable.
- Support Computer System Validation activities including risk assessments, validation planning, requirements traceability, test documentation review, and audit readiness.
- Partner with Quality and Compliance teams to help maintain validated system state and support regulatory inspections or internal audits.
- Stakeholder Management & Leadership
- Serve as a trusted liaison between business stakeholders, technology teams, vendors, implementation partners, Quality, and Compliance.
- Facilitate requirements workshops, solution reviews, walkthroughs, issue triage sessions, and stakeholder alignment discussions.
- Provide guidance, review, and mentoring to less-experienced Business Systems Analysts.
- Contribute to business analysis standards, documentation quality, re-usable templates, and consistent delivery practices within the PV Technology department.
- Communicate complex business, regulatory, and technical topics clearly to both technical and non-technical audiences.
Required Qualifications
- Education & Experience
- Bachelor’s degree in Life Sciences, Pharmacy, Computer Science, Information Systems, Business, or a related discipline.
- 8+ years of experience in Business Analysis, Systems Analysis, Product Analysis, or Technology Delivery.
- 5+ years of experience supporting Pharmacovigilance, Drug Safety, or Safety Technology systems.
- Demonstrated experience supporting complex, cross-functional technology initiatives in a regulated environment.
- Mandatory Domain & Regulatory Experience
- Mandatory experience with PMDA pharmacovigilance requirements, Japan-specific safety reporting processes, and E2B reporting standards.
- Strong understanding of PV business processes such as case processing, intake, triage, reporting, reconciliation, literature management, submissions, and compliance operations.
- Good understanding of GxP and Computer System Validation concepts in regulated technology environments.
- Safety Systems & Technical Skills
- Hands-on experience with pharmacovigilance safety systems such as Oracle Argus Safety, ArisGlobal LifeSphere MultiVigilance, or equivalent PV technology platforms.
- Experience with safety system implementation, enhancement, upgrade, migration, integration, reporting, or production support initiatives.
- Strong Oracle SQL skills for data analysis, troubleshooting, validation support, and requirements clarification.
- Understanding of SDLC methodologies including Agile, Waterfall, or hybrid delivery models.
Preferred Qualifications
- Working knowledge of FDA, EMA, ICH, and other global pharmacovigilance regulations.
- Experience in pharmaceutical, biotechnology, CRO, or life sciences technology environments.
- Experience with Oracle Argus Insight, reporting tools, data warehouses, analytics platforms, or PV integrations.
- Knowledge of GAMP 5 and risk-based validation approaches.
- Professional certification such as CBAP, PMI-PBA, SAFe, Agile, or equivalent is a plus.
- Experience working with global teams, vendors, offshore delivery teams, and managed services partners.