Director, Drug Safety - Pharmacovigilance Operations

March 18

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Neurelis, Inc.

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Neurelis, Inc. is a neuroscience-based company dedicated to developing innovative treatments for people living with neurological conditions. With a focus on enhancing therapeutic benefits and addressing unmet needs in care, Neurelis is committed to empowering individuals to define their own journey. The company boasts a range of proprietary non-invasive drug delivery technologies, including Intravail, ProTek, and Hydrogel, which enhance drug development and clinical performance. Neurelis's pipeline includes several FDA-approved treatments and investigational product candidates at various stages of development. Neurelis is also involved in community activities and offers saving and support programs to ensure accessibility of their therapies.

51 - 200 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• The Director, Drug Safety & Pharmacovigilance Operations will be responsible for managing safety and PV related activities involving VALTOCO® (diazepam nasal spray) and Neurelis’ suite of investigational compounds. • This role will manage external pharmacovigilance vendors regarding the collection, processing and reconciliation of drug safety information and ensure these operations are conducted in compliance with applicable regulations, guidelines and standards. • This person will supervise the development of periodic safety reports to meet our regulatory submission obligations, lead cross-departmental discussions on reportable events (AEs/PCs), and function as a primary drug safety/PV contact for both internal colleagues and external stakeholders. • This position requires a subject matter expert who can focus on tactical execution, provide direction on process improvements and contribute to the strategic buildout of the department. • The Director, Drug Safety & PV Operations will participate in the implementation and maintenance of the Global Safety Database, and help develop ex-US drug safety reporting procedures to ensure compliance with global adverse event reporting requirements.

🎯 Requirements

• BS in life sciences/pharmacy/nursing or related field required. • A minimum of 10 years drug safety/pharmacovigilance experience with a pharmaceutical or biotech company. • Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines). • Demonstrated success with drug safety case processing combined with a thorough knowledge of drug safety database utilization, systems and applications. • Able to effectively manage multiple vendors related to drug safety/pharmacovigilance operations. • Prior experience in overseeing periodic safety data reports and handling expedited cases. • Prior success in the development and implementation of SDEAs, SMPs, RMPs, SOPs and related processes/operations is preferred. • Excellent communication and organization skills.