Director, Pharmacovigilance Operations

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.

This role is a US remote-based position.

Responsibilities:

• Oversees the activities for monitoring adverse event reports for potential drug-safety-related issues and provides recommendations when potential issues are identified
• Oversees the PV vendors/service providers to ensure that they fulfill their accountabilities and responsibilities for all outsourced PV activities
• Act as a Subject Matter Expert (SME) regarding the processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Catalyst products
• Ensures that adverse events from spontaneous cases, solicited cases, and studies and programs involving Catalyst products are collected, reported, and handled in accordance with global/local regulatory requirements and company policies
• Reviews, updates, or writes company SOPs related to Pharmacovigilance and safety reporting to ensure their compliance with EMA, ICH, and FDA guidelines
• Facilitates and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs
• Collaborates with and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives
• Handle assignment of adverse event (AE) & product complaint (PC) training globally to vendors
• Lead, or participate in, as requested, initiatives to continuously enhance the effectiveness and efficiency of PV processes by gathering, analyzing, and communicating relevant metrics on the performance of the processes
• Collaborates with corporate partners to ensure proper exchange of drug-safety data
  
  

Education/Experience/Skills:

• 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) isrequired
• 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
  
  

EEO Statement

Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.

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