Sr. Pharmacovigilance (PV) Clinical Scientist

Job Description

Seeking a Sr. Pharmacovigilance Clinical Scientist to support pharmacovigilance compliance activities within the US Patient Safety organization. This role is responsible for the clinical review, evaluation, processing, and quality oversight of adverse event reports and Individual Case Safety Reports (ICSRs), while ensuring compliance with global safety regulations and internal procedures.

• Perform clinical review, evaluation, and processing of adverse event reports and Individual Case Safety Reports (ICSRs)
• Conduct case triage, medical assessment, seriousness, validity, causality, and labeling evaluations
• Ensure timely and compliant case processing within the global safety database
• Lead quality review activities for in-house and vendor-processed safety cases
• Monitor ICSR quality trends, perform trend analyses, and escalate compliance risks as needed
• Develop executive summaries and metrics related to pharmacovigilance quality and compliance
• Support Health Authority submissions and ensure adherence to local and global regulatory requirements
• Manage follow-up activities, correspondence workflows, and data corrections within safety systems
• Identify process gaps and lead SOP updates, process improvements, and training initiatives
• Support adverse event reconciliation, Case Transmission Verification (CTV), and safety data exchange activities
• Collaborate with internal teams, vendors, and regulatory stakeholders on pharmacovigilance operations
• Provide support during audits, inspections, and regulatory assessments
• Develop and deliver patient safety presentations and training materials

Required Skills

• Pharmacovigilance operations
• Individual Case Safety Report (ICSR) processing
• Adverse event (AE) management
• Clinical review and medical assessment
• Case triage, seriousness, validity, and causality assessment
• Safety database management
• Health Authority submissions
• FDA safety regulations
• ICH guidelines
• EMA regulations
• Global pharmacovigilance compliance
• Safety data reconciliation
• Case Transmission Verification (CTV)
• Vendor oversight and compliance management
• SOP authoring and process improvement
• Technical Product Complaints (TPC)
• Medical Product Complaints (MPC)
• Safety trend analysis and risk assessment
• Training development and delivery
• Audit and inspection support
• Project management

Preferred Skills

• Experience with global safety databases
• Government-sponsored pharmacovigilance programs
• Cross-functional safety data exchange
• Pharmacovigilance quality management
• Regulatory impact assessments
• Subject matter expertise in safety compliance operations
• Executive presentation development