Vice President/Head of Pharmacovigilance

About Soleno Therapeutics Inc

Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS. 

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way. 

Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact—and making history.We all share the most important goal of bringing solutions to the PWS community. 

Summary of Job (brief description)

The VP/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.

The ideal candidate will be a medical doctor (MD or equivalent) with extensive pharmacovigilance and risk management experience across the product lifecycle, including pre- and post-marketing, with demonstrated leadership in rare disease and/or endocrine/CNS therapeutic areas. Experience with US and EU regulatory environments is required; experience with other international health authorities (e.g., PMDA, MHRA, Health Canada, etc.) is highly desired.

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 di