Director, Pharmacovigilance Operations

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Catalyst Pharmaceuticals, Inc.

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Neurology • Neuromuscular • Pharmaceuticals • Rare Disease

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Description

• Catalyst Pharmaceuticals is searching for an experienced Director of Pharmacovigilance (PV) Operations who will provide oversight and management of vendors, business partners, and individuals involved with the Individual Case Safety Report (ICSR) process to ensure efficiency, quality, and compliance with internal procedures and global regulations. • They will also oversee global safety database activities including serious adverse event reporting metrics, support individual study teams, and collaborate on the support of risk management and pharmacovigilance for all Catalyst products. • Additionally, they will lead the planning, execution, and implementation of process improvements, procedures, and solutions related to pharmacovigilance and ICSR reporting.

Requirements

• Bachelor’s degree (preferably in a science or health-related field) and a master preferred • A minimum of 10 years of experience in Pharmacovigilance with strong experience preferred in Pharmacovigilance Operations and PV affiliate Operations • Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations, European Union (EU) Volume 10 clinical trials directive, Guideline on Good Pharmacovigilance Practices (GVP), and ICH Guidelines) is required • Knowledge of MedDRA terminology and its application required • Proficiency with standard desktop computing programs (e-mail, Word, Excel) and relational databases required • Expertise in PV regulations and implementation of PV processes • Significant experience with management of commercial programs and oversight for PV controls • Experience with Health Authority Inspection interviews/process and management • Strong communication and ability to partner closely and effectively cross-functionally and cross-regionally • Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence greater outcomes • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders to develop relevant and realistic plans, programs, and recommendations • Excellent analytical skills and an ability to communicate complex issues in a simple way and propose solutions • Ability to manage multiple, complex projects in a fast-paced environment