PV Ops Lead: Case Management & Strategic Partnerships

AVEO Pharmaceuticals; Boston (MA); Presencial; USD 160 000 - 230 000; Tempo integral

Resumo da oferta

AVEO Pharmaceuticals seeks an Associate Director to oversee Case Management and Strategic Partnerships within Global PV Operations. You will lead outsourced ICSR processing, vendor oversight, and ensure alignment with global PV requirements and safety reporting obligations.

You will collaborate with cross-functional stakeholders to strengthen the PV quality system, drive improvements, and maintain inspection readiness while guiding change management and training related to PV agreements and

Qualificações

• Bachelor’s degree required in life science or healthcare field.
• 8+ years pharmacovigilance experience in biotech/pharma.
• 5+ years overseeing outsourced PV vendors and KPI evaluation.
• Experience with Argus Safety and safety database outputs.

Responsabilidades

• Lead ICSR processing and case management for outsourced vendors.
• Oversee PV vendor performance, KPIs, and compliance.
• Ensure alignment with global PV requirements and study-specific safety reporting obligations.
• Provide strategic guidance and governance for PV SOPs, templates, and policies.
• Collaborate with cross-functional stakeholders to resolve safety issues and maintain inspection readiness.
• Support PV audits/inspections with case documentation and responses.
• Track compliance trends and support CAPAs within PV quality system.
• Identify process gaps and implement sustainable improvements.
• Develop and maintain PV agreements with partners.

Conhecimentos

Vendor oversight

Cross-functional leadership

PV regulatory knowledge

Change management

Formação académica

Bachelor's degree in life science or healthcare-related field

Ferramentas

Argus Safety

Excel

Descrição da oferta de emprego

AVEO Pharmaceuticals seeks an Associate Director to oversee Case Management and Strategic Partnerships within Global PV Operations. You will lead outsourced ICSR processing, vendor oversight, and ensure alignment with global PV requirements and safety reporting obligations.

You will collaborate with cross-functional stakeholders to strengthen the PV quality system, drive improvements, and maintain inspection readiness while guiding change management and training related to PV agreements and