Senior Business Analyst (Pharmacovigilance Technology)

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.

Education & Experience

Bachelors 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.

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.

PV Domain Expertise

Strong understanding of pharmacovigilance operations safety systems Japan PV requirements and compliance expectations.

Business Analysis Leadership

Ability to lead requirements definition documentation impact assessment and solution alignment for complex initiatives.

Regulatory & Validation Mindset

Practical understanding of GxP CSV traceability audit readiness and validated system controls.

Technical Fluency

Comfortable working with safety platforms SQL integrations data flows and SDLC delivery teams.

Stakeholder Management

Able to communicate clearly with business quality compliance vendor and technical stakeholders.

Mentorship

Guides junior analysts and contributes to consistent BA standards and delivery practices.