Principal Pharmacovigilance Specialist, Case Processing

TL;DR

Principal Pharmacovigilance Specialist, Case Processing (Pharmacovigilance/Case Processing): Providing directional leadership for client pharmacovigilance services, complex case processing, regulatory compliance, and safety database operations with an accent on global safety requirements, case quality, and client delivery. Focus on reviewing and creating case narratives, managing escalated inquiries, developing PV documentation, and mentoring case processing staff.

Location: United States; remote work is supported, with hybrid work encouraged for new hires living within a reasonably short commute of a hirify.global office.

Company

hirify.global provides regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology consulting solutions for biotech, medical device, and pharmaceutical organizations.

What you will do

• Provide PV subject-matter expertise and directional oversight for internal and external clients.
• Oversee project-specific working practices, work instructions, safety data exchange agreements, and PV agreements.
• Support complex case processing, escalated inquiries, follow-up activities, client notifications, and healthcare professional reviews.
• Create and review case narratives and perform peer reviews for quality, consistency, and accuracy.
• Maintain current knowledge of global safety regulations and ensure compliance with applicable regulations and internal SOPs.
• Develop and deliver training while mentoring less experienced staff.

Requirements

• Bachelor’s degree in life sciences required.
• Four years of related work experience required.
• Advanced pharmacovigilance knowledge and experience with PV systems such as Oracle Argus Safety, ARISg, or similar safety databases.
• Strong communication, project management, organization, prioritization, problem-solving, and attention-to-detail skills.
• Ability to work independently and collaboratively while managing multiple projects and clients.

Nice to have

• Advanced degree, RN, RPh, PharmD, or equivalent.

Culture & Benefits

• Remote working is supported, with flexibility to work from a hirify.global office when appropriate.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Collaborative and entrepreneurial environment that encourages innovation.
• Applications are personally reviewed by the recruitment team without AI screening tools.
• Applicants receive an outcome regarding their application.