Senior Director, Global Pharmacovigilance & QPPV

Belite Bio, Inc.

Zürich

Remote

CHF 180,000 - 250,000

Full time

14 days+

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Job summary

Belite Bio is seeking an experienced Senior Director, QPPV, Quality & GPV Compliance to lead global pharmacovigilance strategy and ensure inspection readiness. You will serve as the QPPV with primary responsibility for PV quality, compliance, and the global PV system.

You will collaborate with Medical Safety, Regulatory Affairs, Quality, and regional teams to build a scalable PV organization, support regulatory submissions, and supervise outsourced PV activities as Belite prepares for

Qualifications

Advanced degree in medicine, pharmacy, life sciences, nursing, public health, or related field.
10+ years in pharmacovigilance/drug safety with PV quality and compliance experience.
Experience with EU/UK/US/Japan PV regulations and QPPV responsibilities.
Demonstrated leadership and cross-functional collaboration in PV.
Experience overseeing external PV vendors/CROs and PV operations.

Responsibilities

Lead global PV system quality, governance, and inspection readiness.
Act as QPPV and oversee signal detection, aggregate reporting, and risk management.
Develop and maintain PV quality management systems, SOPs, and monitoring.
Coordinate regulatory submissions and health authority interactions.
Oversee inspections and CAPA processes, vendor performance, and CRO relations.
Drive global PV strategy for product launches and post-marketing activities.