Director, Medical Safety (AI)

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, with travel of up to 15%.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Lead, mentor, and develop a team of pharmacovigilance scientists.
• Allocate resources across products and development programs to deliver safety activities on time.
• Oversee signal detection, signal evaluation, safety governance, and benefit-risk assessments for investigational and marketed products.
• Lead the preparation and lifecycle management of Risk Management Plans, safety information, investigator brochures, product labeling, and aggregate safety reports.
• Support pharmacovigilance activities from first-in-human studies through post-marketing, including regulatory submissions, inspections, audits, CAPAs, and compliance initiatives.
• Evaluate and implement AI-enabled tools for signal detection, aggregate reporting, literature surveillance, case review, data quality, and workflow optimization.

Requirements

• Master’s degree or PhD in Pharmacy, Pharmacology, Life Sciences, Nursing, Public Health, or a related scientific discipline.
• At least 10 years of experience in the pharmaceutical or biotechnology industry and at least 5 years of direct people management experience leading pharmacovigilance scientists or medical safety professionals.
• Experience supporting both clinical development and post-marketing pharmacovigilance activities throughout the product lifecycle.
• Extensive experience with signal detection and management, Risk Management Plans, aRMM, REM, DSURs, PSURs/PBRERs, and Annual Reports.
• Thorough knowledge of ICH guidelines and FDA, EMA, and global pharmacovigilance regulations.
• Strong leadership, scientific, analytical, project management, communication, and stakeholder-influence skills, plus experience with AI, automation, and advanced analytics in pharmacovigilance.

Nice to have

• Advanced scientific degree.
• Experience in pulmonary disease, rare diseases, or gene therapy.
• Experience participating in regulatory inspections and audits or leading global pharmacovigilance initiatives.
• Familiarity with safety data visualization, signal detection methodologies, or matrixed global organizations.

Culture & Benefits

• Mission-driven environment focused on serious and rare diseases and meaningful patient outcomes.
• Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, leadership development, mentorship, employee resource groups, and service opportunities.