Director – Senior Director, Pharmacovigilance Operations

🕒 Outubro 2

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $255.000 - $315.000 / ano

⏰ Tempo Integral

🟠 Sênior

⚙️ Operações

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Rezolute, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $96.900.000 Post-IPO Equity - Rezolute em 2025-04

Healthcare • Biotechnology • Pharmaceuticals

A Rezolute, Inc. é uma empresa biofarmacêutica focada no desenvolvimento e entrega de novas terapias para distúrbios metabólicos raros, especificamente o hiperinsulinismo. O principal programa da empresa, ersodetug, conta com dois programas de Fase 3 visando o hiperinsulinismo congênito e tumoral. A Rezolute realiza ensaios clínicos, estudos iniciados por investigadores e publica resultados clínicos. A empresa também se envolve com pacientes, investidores e a comunidade médica para melhorar o cuidado e a qualidade de vida dos pacientes e famílias afetados.

Descrição

• Develop and execute the pharmacovigilance strategy supporting late-stage clinical development, regulatory approval, product launch, and post-marketing surveillance • Establish a scalable PV operating model for the anticipated commercial footprint, product portfolio, geographic expansion, and partnership structure • Serve as a senior safety leader and subject matter expert across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Legal, and other functions • Provide safety input into clinical development plans, regulatory submissions, labeling strategies, launch-readiness activities, medical information processes, and lifecycle management • Represent Pharmacovigilance on cross-functional governance and product development teams • Lead PV readiness activities for transition from clinical-stage to commercial-stage pharmacovigilance • Develop and maintain a comprehensive PV launch-readiness plan • Establish processes for adverse event and product complaint intake, reconciliation, escalation, and reporting • Establish PV requirements and training for employees, contractors, vendors, field-based personnel, and other groups receiving adverse event information • Ensure PV systems, procedures, resources, vendors, and governance structures are operational and inspection-ready before product launch • Establish and oversee signal detection, validation, prioritization, assessment, management, and documentation • Lead cross-functional safety review or Safety Management Team meetings • Oversee aggregate safety reports and periodic benefit-risk assessments, including DSURs, PBRERs/PSURs, and other periodic reports • Lead or contribute to Risk Management Plans and risk minimization activities • Partner with Regulatory Affairs and Clinical Development on labeling changes, investigator communications, regulatory responses, and health authority interactions • Provide strategic and operational oversight of adverse event case management across clinical and post-marketing sources • Ensure collection, assessment, processing, follow-up, quality review, and submission of ICSRs within regulatory timelines • Oversee PV vendors, including safety database, case-processing, medical review, literature surveillance, and aggregate reporting providers • Establish operational metrics, quality indicators, and vendor performance measures • Develop internal versus outsourced capabilities based on company growth, volume, geographic footprint, and portfolio requirements • Ensure reconciliation of safety information across clinical databases, medical information, quality/product complaints, partners, patient support programs, and other systems • Partner with Quality Assurance to establish and maintain the pharmacovigilance quality system • Develop, implement, and maintain PV policies, SOPs, work instructions, and controlled processes • Establish deviation, CAPA, quality-event, and compliance-monitoring processes • Maintain continuous PV inspection readiness and participate in regulatory authority, partner, vendor, and internal audits • Ensure documentation demonstrates effective oversight of outsourced PV activities • Support PV system documentation and regulatory requirements, including the PSMF where required • Develop and maintain SDEAs and pharmacovigilance provisions in licensing, distribution, co-development, and commercialization agreements • Establish responsibilities for case exchange, aggregate reporting, signal management, regulatory submissions, reconciliation, and safety governance • Represent the company on joint safety committees and alliance governance forums • Monitor partner compliance with contractual PV obligations and implement corrective actions • Maintain current knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, and other relevant health authorities • Ensure PV processes remain compliant as products transition from investigational to marketed status and expand geographically • Support health authority meetings and responses to regulatory questions regarding product safety and benefit-risk

🎯 Requisitos

• Advanced degree in a health or life sciences discipline strongly preferred, such as MD, PharmD, PhD, RN/NP, or equivalent scientific/medical training • Candidates with a master's or bachelor's degree and significant relevant pharmacovigilance leadership experience may also be considered • Director: Typically 10+ years of pharmaceutical/biotechnology industry experience, including approximately 7+ years in pharmacovigilance/drug safety • Senior Director: Typically 12–15+ years of pharmaceutical/biotechnology industry experience with substantial progressive leadership responsibility within pharmacovigilance • Demonstrated experience supporting late-stage clinical development and/or marketed products • Experience managing outsourced PV operations and vendors • Senior Director: demonstrated leadership of PV activities through late-stage development, regulatory approval, and commercial launch • Senior Director: experience establishing or significantly scaling a pharmacovigilance function • Experience interacting with senior executives, health authorities, strategic partners, and regulatory inspectors • Strong working knowledge of global pharmacovigilance regulations and regulatory reporting requirements • Strong working knowledge of ICSR management and expedited reporting • Strong working knowledge of signal detection and signal management • Strong working knowledge of aggregate safety reporting • Strong working knowledge of benefit-risk assessment • Strong working knowledge of risk management planning and risk minimization • Strong working knowledge of safety governance • Strong working knowledge of safety database and PV technology environments • Strong working knowledge of SDEAs and partner pharmacovigilance oversight • Strong working knowledge of vendor governance and outsourced PV models • Strong working knowledge of PV quality systems, CAPAs, audits, and inspection readiness • Strong working knowledge of clinical-to-commercial PV transition • Experience with commercial safety systems such as Oracle Argus Safety or equivalent validated safety database platforms is desirable

🏖️ Benefícios

• Annual performance bonus • Health Insurance (Medical / Dental / Vision) • Disability, Life & Long-Term Care Insurance • Holiday Pay • Tracking Free Vacation Program • 401(k) Plan Match • Educational Assistance Benefit • Fitness Center Reimbursement

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