IT Business Analyst - Pharmacovigilance

Description

We are seeking an experienced IT Business Analyst with strong Pharmacovigilance (PV) domain expertise to support the design, implementation, enhancement, and maintenance of safety systems and technology solutions. The successful candidate will act as a liaison between Pharmacovigilance business teams, IT, vendors, and other stakeholders to ensure that safety processes and systems meet regulatory, operational, and business requirements.

Requirements

Key Responsibilities

Gather, analyze, document, and validate business and system requirements for Pharmacovigilance applications.

Work closely with Drug Safety, Case Processing, Medical Safety, Regulatory Affairs, Quality, Clinical Operations, and IT teams.

Translate PV business processes into functional and technical requirements.

Support the implementation and enhancement of safety databases, case management systems, signal management tools, aggregate reporting systems, and related platforms.

Analyze current processes, identify gaps, and recommend improvements aligned with business and regulatory needs.

Create business requirements documents, functional specifications, user stories, process maps, workflow diagrams, and use cases.

• Facilitate workshops, interviews, requirement reviews, and stakeholder meetings.
• Support system configuration, integration, data migration, and interface requirements.

Ensure solutions support key PV processes, including

• Individual Case Safety Report management
• Adverse event intake and triage
• Case processing and medical review
• Follow-up management
• Safety reporting and submissions
• Signal detection and management
• Aggregate reporting
• Product and reference data management
• Literature surveillance
• Reconciliation processes

Pharmacovigilance agreements and compliance tracking

Support validation activities in accordance with GxP, CSV/CSA, and company quality procedures.

Develop and execute test scenarios, test scripts, and acceptance criteria.

Coordinate and support System Integration Testing, User Acceptance Testing, regression testing, and defect management.

• Investigate system issues and coordinate with technical teams and vendors on resolution.
• Support data analysis, reporting, and reconciliation activities.

Ensure systems and processes comply with applicable Pharmacovigilance regulations, company standards, and audit requirements.

Prepare training materials and provide support to end users.

Contribute to system releases, change controls, risk assessments, and implementation planning.

Maintain clear documentation and traceability throughout the project lifecycle.

Required Qualifications and Experience

Bachelor's degree in Information Technology, Computer Science, Life Sciences, Pharmacy, or a related field.

Typically 5+ years of experience as a Business Analyst, with significant experience in Pharmacovigilance or Drug Safety.

• Strong understanding of end-to-end Pharmacovigilance processes and safety case management.
• Experience working with Pharmacovigilance or safety systems such as:
• Oracle Argus Safety
• ArisGlobal LifeSphere Safety
• Veeva Safety
• Medidata Safety Gateway

Safety Easy or similar platforms

Experience with requirements management, process modeling, system implementation, and software development life cycle methodologies.

Experience in GxP-regulated environments and computer system validation.

Knowledge of safety data standards and regulatory requirements, including MedDRA, E2B, ICSR, and relevant health authority reporting expectations.

• Experience in testing, defect management, release management, and change control.
• Strong skills in stakeholder management and cross-functional communication.

Ability to work effectively with business users, developers, QA teams, vendors, and senior management.

Preferred Qualifications

• Experience with Pharmacovigilance system integrations and data interfaces.
• Knowledge of E2B(R2/R3), XML, API, web services, and data mapping.
• Familiarity with Agile, Scrum, Waterfall, or hybrid delivery methodologies.

Experience with tools such as Jira, Confluence, Azure DevOps, HP ALM, or similar platforms.

• Knowledge of SQL, data analysis, reporting tools, and database concepts.
• Experience supporting audits, inspections, and regulatory commitments.

Experience in pharmaceutical, biotechnology, contract research organization, or healthcare environments.

Key Skills

• Pharmacovigilance and Drug Safety domain expertise
• Business and systems analysis
• Requirements elicitation and documentation
• Process mapping and optimization
• Stakeholder and vendor management
• Functional and integration testing
• GxP and CSV/CSA compliance
• Data analysis and reconciliation
• Problem-solving and root-cause analysis
• Excellent written and verbal communication
• Strong organizational and documentation skills

Typical Deliverables

• Business Requirements Documents
• Functional Requirements Specifications
• User stories and acceptance criteria
• Process flows and workflow diagrams
• Data mapping and interface specifications
• Test plans, test scripts, and traceability matrices
• Impact assessments and gap analyses
• Training and user-support documentation
• Change requests and release documentation

Employment Details

• Job Title: IT Business Analyst - Pharmacovigilance
• Department: Information Technology / R&D Technology
• Reports To: Product Owner, Patient Safety
• Location: Cambridge, MA - on-site 5 days per month
• Employment Type: 1-year Contract
• Travel: Occasional travel may be required
• Experience Level: Mid-Level (5-7 years)