Job Description

Senior Safety Domain Expert - Falcon

This is a senior pharmacovigilance role at the intersection of drug safety operations, technology, and artificial intelligence. You will bring deep hands-on PV expertise to the development of next-generation safety automation solutions. The role combines detailed workflow knowledge with strategic thinking about how pharmacovigilance is evolving through digital transformation. You will work closely with product and engineering teams to validate AI-driven capabilities and ensure they meet demanding operational and compliance standards. You will also engage directly with early adopter organizations, serving as a trusted voice for customer needs and translating feedback into meaningful product improvements. This is an opportunity to influence the future of PV operations while working in a highly collaborative, technology-driven environment.

Accountabilities:

• Provide expert guidance on end-to-end pharmacovigilance workflows, including safety case intake, triage, validation, processing, reconciliation, and expedited reporting activities.
• Advise product and engineering teams on detailed operational requirements and real-world PV processes to ensure automation solutions accurately reflect industry practices.
• Review, evaluate, and verify AI-generated outputs across safety case intake and processing workflows, identifying gaps and opportunities to improve precision, accuracy, reliability, and compliance.
• Translate emerging pharmacovigilance trends, operational changes, and industry developments into actionable product capabilities and long-term automation strategies.
• Engage directly with PV leaders, case-processing specialists, and early adopter organizations to understand their needs and translate feedback into actionable platform enhancements.
• Act as a strong customer advocate and subject matter expert, bridging the gap between pharmacovigilance operations, technical product development, and customer expectations.
• Design complex, multi-variable safety case scenarios to stress-test AI capabilities and evaluate the boundaries of automated reasoning and workflow execution.
• Contribute to the continuous improvement of AI-driven safety solutions by identifying operational risks, edge cases, and opportunities for enhanced automation.
• Support the evolution of pharmacovigilance operating models by bringing practical expertise and strategic insight into the future of digital and automated safety operations.

Requirements:

• 5+ years of active professional experience in Pharmacovigilance, Drug Safety Operations, or a closely related field.
• Deep practical knowledge of day-to-day safety case processing, including case intake, triage, validation criteria, database reconciliation, and global expedited reporting timelines.
• Strong understanding of pharmacovigilance operations and a strategic perspective on how PV operating models are evolving through automation, artificial intelligence, and digital transformation.
• Demonstrated experience with AI-driven software, automated workflows, agentic AI, machine learning applications, or similar technologies within pharmacovigilance, drug safety, or the broader life sciences industry.
• Ability to translate complex operational requirements into clear guidance for product, engineering, and technical teams.
• Strong customer-facing communication skills and confidence presenting technical and operational concepts to senior or executive-level stakeholders.
• Analytical and structured approach to evaluating AI outputs, identifying edge cases, and assessing workflow performance and compliance.
• Experience contributing to the design, implementation, or user-acceptance testing of automated pharmacovigilance intake solutions is highly valued.
• Ability to operate effectively in a collaborative, fast-moving environment while balancing detailed operational execution with strategic thinking.

Benefits:

• Competitive base salary of $130,000–$180,000 CAD annually, with actual compensation determined by experience, location, qualifications, and expected contribution.
• Potential eligibility for additional compensation, including variable bonuses and/or stock-based awards.
• Medical, dental, vision, and basic life insurance coverage.
• Paid time off and company-paid holidays.
• Retirement programs.
• Flexible work-from-home or office arrangements through a Work Anywhere model.
• Opportunities to work at the intersection of pharmacovigilance, artificial intelligence, automation, and life sciences technology.
• A mission-driven environment focused on improving healthcare and accelerating innovation across the life sciences industry.
• A collaborative and inclusive workplace that supports employee development and meaningful professional impact.
• Participation in a 1% charitable giving program.

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