Principal Safety Operations Specialist - Quality Focused
Core
Principal Safety Operations Specialist ensuring quality and compliance in Pharmacovigilance operations, supporting safety project teams with audit readiness and quality improvement initiatives.
Role type
Senior IC Pharmacovigilance Quality Specialist
Builds
Safety submissions, aggregate reports, and quality assurance processes for drug development clients
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Required skills
Pharmacovigilance lifecycle expertise, Literature Review, Safety Submissions, Signal Detection, Safety Surveillance, Aggregate Reporting, Retrospective QC, Root Cause Analysis, Risk-based process assessment, Regulatory compliance knowledge
Preferred skills
Power BI dashboard creation, AI integration, Lean/6 Sigma processes, Relational databases, Clinical research data collection
Technologies
Power BI, SmartSheet, Microsoft Office Suite (Word, Excel, Visio, PowerPoint), SharePoint, Outlook
Responsibilities
Provide controlled document support for quality planning and revisions; Identify and communicate areas of risk through risk-based process assessments; Perform quality control activities and verify quality compliance; Develop and promote quality improvement initiatives and manage corrective and preventive actions; Support safety project teams in maintaining audit and inspection readiness; Participate in root cause analysis processes.
Seniority
Principal, hands-on IC