Senior Director, QPPV, Quality & GPV Compliance, Global Pharmacovigilance

LOCATION: This is a remote role based in the EU, with a preference for Switzerland

About Belite Bio

Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases with significant unmet medical needs. Built on our proprietary Retinol Binding Protein 4 (RBP4) IP portfolio, our clinical pipeline includes Tinlarebant (LBS-008), an oral therapy currently in late-stage clinical trials (including the Phase 3 DRAGON and PHOENIX studies) for Stargardt disease (STGD1) and Geographic Atrophy (GA) in dry AMD.

At Belite Bio, we are dedicated to developing innovative solutions to treat untreatable conditions and prevent vision loss in patients worldwide. As an emerging, agile organization, we offer a fast-paced environment where dynamic self-starters thrive.

Operating at the forefront of drug development means our team members wear multiple hats, roll up their sleeves, and bring deep personal dedication to every project. If you are energized by a high-impact, hands-on culture where your effort directly shapes our growth and mission, you will find a rewarding home here.

About This Role

Belite Bio is seeking an experienced and highly motivated Senior Director, QPPV, Quality & GPV Compliance to provide strategic leadership and oversight of the Company's global pharmacovigilance system.

The successful candidate will serve as the Qualified Person for Pharmacovigilance (QPPV), and will have primary responsibility for PV quality, compliance, inspection readiness, and oversight of the global PV system. This role will be particularly important as Belite Bio prepares for commercialization and expands its pharmacovigilance activities across global markets.

The Senior Director will work closely with Medical Safety, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, Clinical Operations, and regional safety teams, as well as external PV service providers. The role requires a hands-on leader who can establish a fit-for-purpose, scalable, and inspection-ready PV system within a growing biotechnology company.

This role reports directly to the Head of Medical Safety, Global Pharmacovigilance.

Key Responsibilities

1. QPPV & Global PV System Oversight

• Serve as the QPPV, with overall oversight of the Company's global pharmacovigilance system.
• Ensure compliance with applicable global pharmacovigilance regulations, guidelines, and company procedures.
• Provide oversight of the Pharmacovigilance System Master File (PSMF) and global PV system documentation.
• Establish and maintain appropriate PV governance, roles, responsibilities, escalation pathways, and decision-making processes.
• Provide senior PV oversight for signal detection and management, aggregate reporting, risk management, safety reporting, and emerging safety issues.
• Ensure timely escalation and appropriate management of significant safety signals and urgent safety issues.
• Provide PV leadership and input to global regulatory submissions and health authority interactions.

1. PV Quality & Compliance

• Lead the development, implementation, and continuous improvement of the PV Quality Management System.
• Establish and maintain PV SOPs, policies, work instructions, and quality standards.
• Develop and implement risk-based PV compliance monitoring and oversight processes.
• Oversee deviations, CAPAs, quality issues, and compliance activities related to pharmacovigilance.
• Establish and monitor appropriate PV quality metrics and KPIs.
• Ensure compliance with requirements for ICSR reporting, aggregate reporting, signal management, risk management, literature monitoring, and other PV obligations.
• Promote a culture of quality, accountability, compliance, and continuous improvement across the organization.

1. Inspection Readiness

• Lead the Company's global PV inspection readiness program.
• Maintain a continuously inspection-ready PV system across global operations.
• Coordinate preparation for regulatory inspections and PV-related audits, including mock inspections and interview preparation.
• Serve as a key PV representative during health authority inspections.
• Lead the development and implementation of responses and CAPAs arising from inspections, audits, and compliance assessments.
• Monitor regulatory and inspection trends and translate them into improvements to the PV system.

1. Vendor & Partner Oversight

• Provide strategic oversight of outsourced PV activities and ensure appropriate internal accountability for vendor performance.
• Oversee PV vendors and CROs, including quality metrics, KPIs, compliance, deviations, and CAPAs.
• Support development and maintenance of Safety Data Exchange Agreements (SDEAs) and other PV agreements.
• Ensure effective oversight of external partners supporting case processing, safety reporting, database activities, and other PV operations.

1. Global & Cross-Functional Leadership

• Partner with Medical Safety and Safety Physicians on signal evaluation, benefit-risk assessment, and safety governance.
• Collaborate with Regulatory Affairs, Quality, Clinical, Medical Affairs, and regional teams to ensure consistent global PV practices.
• Provide PV oversight and support for product launch and post-marketing activities in the US, EU/UK, Japan, Australia, and other markets.
• Help build and develop a lean, scalable global PV organization using appropriate internal resources and qualified external partners.
• Mentor and develop PV professionals and regional safety team members.

Qualifications & Experience

• Advanced degrees in medicine, pharmacy, life sciences, nursing, public health, or a related scientific discipline preferred
• 10+ years of progressive experience in pharmacovigilance/drug safety, including substantial experience in PV quality and compliance.
• Extensive experience with global PV regulations and requirements, including EU, UK, US, and Japan.
• Demonstrated experience serving as or supporting a QPPV or equivalent senior PV accountable role.
• Strong knowledge of PV quality systems, compliance, audits, CAPA, and inspection readiness.
• Experience overseeing external PV vendors/CROs and global PV operations.
• Strong understanding of ICH, GVP, CIOMS, and applicable regional PV requirements.
• Excellent leadership, communication, problem-solving, and cross-functional collaboration skills.

Preferred Qualification

• Previous experience serving as a QPPV, particularly in support of the first global product launch and establishment of a commercial PV system.
• Experience developing and maintaining a global PSMF and associated PV quality documentation.
• Experience supporting global product launches and post-marketing pharmacovigilance.
• Proven experience leading successful health authority PV inspections and/or major compliance remediation programs.
• Experience interacting directly with FDA, EMA, MHRA, PMDA, and other health authorities.
• Strong knowledge of Japan PV requirements and PMDA interactions, as well as EU/UK QPPV requirements.
• Experience establishing or transitioning a global safety database and PV operating model from CRO-supported development to an internal commercial PV organization.
• Experience with Argus or other validated global safety databases.
• Experience conducting or participating in mock inspections and regulatory inspection simulations.
• Experience developing risk-based vendor oversight, compliance monitoring, and PV governance frameworks.
• Experience developing and implementing risk-based PV compliance strategies.
• Experience with rare disease and/or ophthalmology products.

Equal Employment Opportunity & Accommodations

Belite Bio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Belite Bio is committed to working with and providing reasonable accommodation to individuals with disabilities. If you need reasonable accommodation for any part of the application or interviewing process due to a medical condition or disability, please contact human resources to let us know the nature of your request.