Head of Pharmacovigilance

Overview

Join to apply for the Head of Pharmacovigilance role at 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. We are driven by the needs of the PWS community and value collaboration, integrity, and respect. We are expanding across functions and invite you to join us in making an impact—and making history. The goal is to bring solutions to the PWS community.

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 expands 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 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

Salary Range : $315,000 - $355,000

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