Soleno Therapeutics, Inc. · 1 day ago
Head of Pharmacovigilance
Redwood City, CA
Full-time
Onsite
Director/Executive
$315K/yr - $355K/yr
12+ years expSoleno Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Head of Pharmacovigilance will lead the global pharmacovigilance function, ensuring patient safety, regulatory compliance, and proactive benefit-risk management.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
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
Ability to operate both strategically and hands-on in a fast-paced, entrepreneurial setting
Preferred
Experience supporting commercial product(s) in rare disease, endocrine/metabolic or CNS therapeutic areas preferred
Experience with rare or neuroendocrine diseases
Company
Soleno Therapeutics, Inc.
At Soleno Therapeutics, we believe in the power of science, advocacy, and community.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$569.2MKey Investors
Oxford Finance LLCAbingworth
2025-07-10Post Ipo Equity· $200M
2024-12-17Post Ipo Debt· $50M
2024-05-02Post Ipo Equity· $158.7M
Leadership Team
Jim Mackaness
Chief Financial Officer
Recent News
2026-01-06
Company data provided by crunchbase