Senior Director, QPPV, Quality & GPV Compliance

The role of Senior Director, QPPV, Quality & GPV Compliance at Belite Bio involves providing strategic leadership and oversight of the company's global pharmacovigilance system. Belite Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for retinal degenerative eye diseases, with a strong emphasis on addressing significant unmet medical needs. The main day-to-day responsibilities include serving as the Qualified Person for Pharmacovigilance (QPPV), ensuring compliance with global pharmacovigilance regulations, and overseeing the Pharmacovigilance System Master File (PSMF) and global PV system documentation. The role also involves establishing and maintaining appropriate PV governance, roles, responsibilities, escalation pathways, and decision-making processes. Additionally, the Senior Director will provide senior PV oversight for signal detection and management, aggregate reporting, risk management, safety reporting, and emerging safety issues. They will also lead the development, implementation, and continuous improvement of the PV Quality Management System, and establish and maintain PV SOPs, policies, work instructions, and quality standards. The must-have requirements for this role include an advanced degree in medicine, pharmacy, life sciences, nursing, public health, or a related scientific discipline, 10+ years of progressive experience in pharmacovigilance/drug safety, including substantial experience in PV quality and compliance, and extensive experience with global PV regulations and requirements. The role also requires proficiency in English. Nice-to-have skills include the ability to work closely with various teams such as Medical Safety, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, Clinical Operations, and regional safety teams, as well as external PV service providers. The role is based remotely in the EU, with a preference for Switzerland, and offers a fast-paced environment where dynamic self-starters thrive. The company values a high-impact, hands-on culture where effort directly shapes its growth and mission. What the role asks for: - Advanced degree in medicine, pharmacy, life sciences, nursing, public health, or a related scientific discipline - 10+ years of progressive experience in pharmacovigilance/drug safety - Substantial experience in PV quality and compliance - Extensive experience with global PV regulations and requirements - Proficiency in English