Global PV Operations & Compliance Leader

veratherapeuticsinc; United States; A distancia; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Vera Therapeutics, a Brisbane, California-based biotechnology company, seeks a PV Operations leader to shape global pharmacovigilance strategy and oversee a multidisciplinary team. You will manage budgets, vendor relationships, and safety systems to ensure regulatory compliance across the portfolio.

The role requires deep knowledge of ICH, US and international PV regulations, and experience in post-marketing safety activities, case processing, and inspection readiness.

Formación

• Experience leading pharmacovigilance operations and safety strategy.
• Knowledge of global regulatory requirements and GVP/ICH guidelines.
• Ability to manage budgets, vendors, and cross-functional stakeholders.

Responsabilidades

• Own global PV Operations strategy and budget.
• Act as advisor on operational risk and resource allocation.
• Represent PV Operations with senior leadership and partners.
• Oversee PV staff and talent development.
• Ensure compliant execution of case management and regulatory reporting.
• Lead inspection readiness for Health Authority audits.

Conocimientos

PV Operations

Budget planning

Vendor management

Regulatory compliance

Staff management

Inspection readiness

ICH/GVP knowledge

Safety systems

Herramientas

MedDRA

PV database

Vendor management tools

Descripción del empleo

Vera Therapeutics, a Brisbane, California-based biotechnology company, seeks a PV Operations leader to shape global pharmacovigilance strategy and oversee a multidisciplinary team. You will manage budgets, vendor relationships, and safety systems to ensure regulatory compliance across the portfolio.

The role requires deep knowledge of ICH, US and international PV regulations, and experience in post-marketing safety activities, case processing, and inspection readiness.