Senior QPPV & Global PV Compliance Leader

Belite Bio, Inc.; Zürich; A distancia; CHF 168.000 - 224.000; Jornada completa

Descripción de la vacante

Belite Bio is seeking a Senior Director, QPPV to provide strategic leadership for the company’s global pharmacovigilance system. The role focuses on quality, compliance, inspection readiness, and PV oversight across markets.

As QPPV, you will partner with Medical Safety, Regulatory Affairs, and regional teams to ensure compliant safety operations and timely regulatory submissions while guiding external PV vendors and CROs.

Formación

• Advanced degree in medicine, pharmacy, life sciences or related field.
• 10+ years in pharmacovigilance/drug safety with PV quality and compliance.
• Experience as a QPPV or in a senior PV accountable role.

Responsabilidades

• Oversee the global pharmacovigilance system and QPPV on a day-to-day basis.
• Lead PV quality, compliance, deviations, CAPAs, and inspection readiness.
• Direct PV governance, reporting, risk management, and literature monitoring.
• Coordinate with regulators, safety teams, and external PV vendors.

Conocimientos

Leadership

Communication

Cross-functional collaboration

Problem-solving

Strategic thinking

Educación

Advanced degree in medicine/pharmacy/life sciences

Herramientas

Argus

Descripción del empleo

Belite Bio is seeking a Senior Director, QPPV to provide strategic leadership for the company’s global pharmacovigilance system. The role focuses on quality, compliance, inspection readiness, and PV oversight across markets.

As QPPV, you will partner with Medical Safety, Regulatory Affairs, and regional teams to ensure compliant safety operations and timely regulatory submissions while guiding external PV vendors and CROs.