Safety Data Consultant

We are looking for a Safety Data Consultant with deep expertise in safety data, pharmacovigilance systems, and data modernization initiatives.

As a Safety Data Transformation Consultant, you will help clients transform how Pharmacovigilance data is governed, integrated, standardized, and consumed across the safety landscape. You will work at the intersection of business, data, and technology to deliver modern safety data solutions and data-driven operational improvements.

The ideal candidate combines strong safety domain expertise with experience in data strategy, governance, analytics, and digital transformation programs.

Responsibilities

Safety Data Strategy & Transformation

• Define safety data transformation roadmaps aligned to business and regulatory objectives.
• Assess current-state safety data ecosystems and identify optimization opportunities.
• Drive modernization of safety data platforms, integrations, and reporting capabilities.
• Enable trusted, scalable, and reusable safety data assets.

Data Governance & Standards

• Establish and maintain safety data governance frameworks.
• Define safety data standards, business rules, metadata, and data quality controls.
• Collaborate with Data Owners, Data Stewards, and Technology teams to improve data integrity and traceability.
• Support implementation of sustainable data stewardship practices.

Safety Data Products & Analytics

• Partner with business stakeholders to define requirements for safety data products.
• Support development of data models, analytics platforms, dashboards, and reporting solutions.
• Enable consistent and compliant safety data consumption across the organization.
• Drive adoption of data-driven decision-making practices.

Data Integration & Modernization

• Support data migration, platform consolidation, and system integration initiatives.
• Collaborate with architects and engineering teams on solution design.
• Ensure alignment between business requirements, regulatory expectations, and technical implementation.

Stakeholder Engagement

• Act as a trusted advisor across Safety Operations, Regulatory Affairs, Quality, IT, and Data & Analytics teams.
• Facilitate workshops and requirements discussions.

Provide guidance on safety data best practices and industry trends.

• Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or related discipline.
• 8+ years of experience in Pharmacovigilance Data Management, Safety Analytics, Data Governance, or Safety Data Transformation.
• Strong understanding of end-to-end Pharmacovigilance data lifecycle.
• Experience with data governance, data quality, metadata, and data standards.
• Ability to translate business needs into scalable data solutions.
• Excellent communication and consulting skills.

Preferred Qualifications

• Experience with Oracle Argus Safety and safety data repositories.
• Knowledge of MedDRA, WHO Drug Dictionary, and Pharmacovigilance data standards.
• Experience with Data Lakes, Lakehouses, Cloud Data Platforms, or Enterprise Analytics environments.
• Experience with data migration, data integration, and master data management initiatives.
• Exposure to AI/ML-enabled safety analytics and reporting solutions.