Head of Pharmacovigilance

Role Summary

The Head of Pharmacovigilance will lead Soleno’s global pharmacovigilance function, and be responsible for the medical, strategic and operational oversight of drug safety for both marketed and investigational products. This is a critical leadership role that will ensure patient safety, regulatory compliance, and proactive benefit-risk management as Soleno continues to expand its commercial footprint and global development pipeline.

Responsibilities

• Provide strategic leadership and medical oversight of all pharmacovigilance activities across the company.
• Supervise appropriately designated QPPV functions via partners/vendors in EU and other regions as needed.
• Lead the development, implementation, and ongoing refinement of global PV systems and infrastructure to support commercial and clinical-stage products.
• Oversee case processing, medical safety review, signal detection, risk management plans (RMPs), periodic safety reports (PSURs/PBRERs), and safety-related regulatory submissions.
• Ensure compliance with global regulatory requirements and guidelines (FDA, EMA, MHRA, PMDA, ICH, etc.).
• Support the ongoing commercial launch of VYKAT XR in the U.S. and future launches globally, including label expansions.
• Collaborate cross-functionally with Regulatory Affairs, Clinical Development, Medical Affairs, Quality, Commercial, and external partners.
• Represent PV in Health Authority interactions and inspections; contribute to briefing documents, information requests, and regulatory strategy.
• Partner with Clinical Development on life cycle management/new indications, including protocol design, safety monitoring plans, and safety data exchange agreements.
• Lead safety governance activities including any committees related to signal detection, risk management, and other related governance.
• Oversee selection, management, and performance of external vendors/partners supporting PV functions.

Qualifications

• Medical Doctor (MD) or equivalent degree with U.S. or international clinical training.
• 12+ years of experience in pharmacovigilance and/or medical safety roles within the biopharmaceutical industry, with increasing leadership responsibility.
• Proven track record overseeing global PV and medical safety activities in both pre- and post- approval settings.
• Expertise in regulatory safety requirements across major global markets (U.S., EU); familiarity with Japan, LATAM, and MENA regulations a plus.
• Experience supporting commercial product(s) in rare disease, endocrine/metabolic or CNS therapeutic areas preferred.
• Direct experience in global regulatory submissions and interactions.
• Demonstrated ability to scale PV systems and teams in a growing biotech environment.
• Experience leading pharmacovigilance through global launches and multi-region commercialization.
• Prior involvement in establishing QPPV systems or managing PV partnerships in Europe and other ex-U.S. markets.
• Experience with rare or neuroendocrine diseases.
• Ability to operate both strategically and hands-on in a fast-paced, entrepreneurial setting.

Skills

• Pharmacovigilance leadership
• Regulatory affairs collaboration
• Safety signal detection and risk management
• Global submissions and inspections
• Vendor/partner management
• Life cycle safety planning
• Cross-functional collaboration

Education

• Medical Doctor (MD) or equivalent degree with U.S. or international clinical training