Director, Medical Safety and Pharmacovigilance

Role Summary

The Director, Medical Safety and Pharmacovigilance will provide medical expertise and oversight across Soleno’s clinical and postmarketing safety activities. This physician role is responsible for clinical assessment of adverse events (AEs), including individual case safety reports and aggregate data, as well as signal detection and risk–benefit evaluation. The Director will collaborate closely with pharmacovigilance operations, clinical development, medical affairs, regulatory affairs, and other cross-functional partners to ensure proactive safety surveillance, regulatory compliance, and high-quality safety deliverables.

Responsibilities

• Provide medical review and assessment of individual adverse event reports from clinical trials, spontaneous sources, literature, and postmarketing experience.
• Lead aggregate safety data evaluation, including signal detection, trend analyses, and benefit-risk assessments.
• Contribute to the preparation, authoring, and/or review of aggregate safety reports (DSURs, PBRERs/PSURs, RMPs, safety summaries in regulatory submissions).
• Participate in drafting and reviewing safety-related sections of clinical study protocols, investigator brochures, informed consent forms, and clinical study reports.
• Support safety governance activities, including safety review meetings and signal detection committees.
• Collaborate with pharmacovigilance operations (Director of PV and vendors) to ensure quality, compliance, and timely case processing.
• Author and review responses to regulatory authority safety inquiries (FDA, EMA, MHRA, PMDA, Health Canada, etc.).
• Serve as a medical representative in health authority interactions, inspections, and audits related to safety.
• Provide clinical input into risk management strategies, safety surveillance plans, and labeling updates.
• Partner cross-functionally with Clinical Development, Regulatory, Medical Affairs, and Quality to ensure alignment on safety-related issues.

Qualifications

• Medical Degree (MD, DO, or equivalent); board certification/board eligibility in a relevant specialty (endocrinology, neurology, pediatrics, or related) preferred.
• Minimum 7+ years of experience in pharmacovigilance/drug safety within the biopharmaceutical industry, including direct medical review of adverse events.
• Strong knowledge of global safety regulations and guidelines (FDA, EMA, ICH, GVP, etc.) with experience supporting investigational and marketed products.
• Prior experience in case-level safety assessment, signal detection, aggregate report writing, and risk–benefit evaluation required.
• Experience interacting with U.S. and ex-U.S. health authorities on safety matters.
• Hands-on experience in regulatory responses and authoring/reviewing safety-related regulatory documents.
• Experience in rare diseases and/or endocrine/metabolic therapeutic areas desirable.
• Excellent analytical, communication, and cross-functional collaboration skills.
• Ability to thrive in a fast-paced, entrepreneurial environment while balancing strategic oversight with hands-on execution.