Associate Director, Pharmacovigilance – PV Operations

🕒 vor 1 Monat

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $180.000 - $205.000 / Jahr

⏰ Vollzeit

🟠 Senior

⚙️ Operations

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Nuvalent, Inc.

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11 - 50 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Nuvalent, Inc. ist ein Biotechnologieunternehmen, das sich auf die Entwicklung gezielter Therapien für Krebspatienten konzentriert. Mit einer soliden Basis in der Chemie und der strukturorientierten Arzneimittelforschung entwirft Nuvalent innovative kleine Moleküle, um Kinase-Ziele effektiv zu hemmen und Herausforderungen hinsichtlich Resistenz und Selektivität zu überwinden. Das Unternehmen arbeitet mit forschenden Ärzten zusammen, um Patientenbedürfnisse und die Grenzen bestehender Therapien zu adressieren, wobei ihre Lösungen patientenorientiert und von einem tiefen Sinn für Zweckmäßigkeit getrieben sind. Nuvalent verpflichtet sich, seine Expertise zu nutzen, um präzise zielgerichtete Krebsbehandlungen bereitzustellen.

Beschreibung

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities. • Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans. • Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training. • Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders. • Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs. • As needed. review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports. • Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team. • Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines. • Serve as PV operations SME on safety reporting processes according to study protocol. • Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices. • Serve as resource and contact for other functions within the company for pharmacovigilance operational activities. • Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.

🎯 Anforderungen

• Bachelor’s degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field. • 8-10 years of experience in a biotech/pharma company. • Direct experience managing relationships with service providers or external business partners • Clinical Development experience. • Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS • Ability to interpret and follow regulatory guidelines. • Proven knowledge of Good Documentation Practices and cGXPs. • Basic knowledge of MedDRA coding. • Experience in ICSR case-processing and reporting. • Experience working in and with safety databases.

🏖️ Vorteile

• medical, dental, and vision insurance • 401(k) retirement savings plan • generous paid time off (including a summer and winter company shutdown)