Director/Senior Director of Pharmacovigilance Operations

Summary

Join Recursion Pharmaceuticals as a Senior Director of Pharmacovigilance Operations and manage all aspects of pharmacovigilance operations for investigational compounds in Recursion’s growing clinical pipeline. You will execute PV operations in compliance with regulations, manage outsourced PV activities, partner with clinical teams on PV processes, prepare safety documents, and identify innovative PV processes using AI. This role reports to the Vice President and Head of Pharmacovigilance and is a key part of the Recursion Clinical Development Team. Remote work is considered with occasional office visits required. Compensation includes a competitive salary, bonuses, equity compensation, and a comprehensive benefits package. Recursion values a culture of care, learning, delivery, bold action with integrity, and teamwork.

Requirements

• Life science degree or healthcare professional (PharmD, PhD, MS, BS, RN, or RPh)
• 10+ years of pharmacovigilance operations experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance
• Expert knowledge of global PV regulatory guidelines and legislation requirements, e.g., US Code of Federal Regulations, European Union directives/regulations, Good Pharmacovigilance Practices
• Knowledge of MedDRA and WHO Drug Dictionary
• Demonstrated CRO management experience and study start-up experience

Responsibilities

• Execute pharmacovigilance (PV) operations in compliance with Regulatory requirements to advance the Recursion pipeline
• Manage all outsourced PV activities, including but not limited to vendor oversight and quality review of literature and individual case safety report processing
• Partner with clinical teams to implement PV-related processes such as adverse event reporting, database reconciliation, and 6-month line listing preparation
• Drive preparation of safety documents such as DSURs and support medical pharmacovigilance with initial preparation and review of safety data
• Identify and implement innovative PV processes using artificial intelligence that bolster Recursion’s tech-driven approach to drug development

Preferred Qualifications

Remote work is considered with occasional office visits required

Benefits

• Bonuses
• Equity compensation
• Comprehensive benefits package for United States based candidates