Director, Global Patient Safety Sciences Delivery - General Medicine (Biotech)

Location: Dublin, Ireland; onsite 3 days per week. Travel of up to 25% may be required.

Company

hirify.global is a biotechnology company that develops and commercializes medicines for people with serious diseases.

What you will do

• Lead General Medicine safety operations, including safety data processing, submission creation, documentation, safety surveillance, signal management, and aggregate reporting.
• Coordinate signal detection and signal management activities across Safety Monitoring Teams, Safety Surveillance Plans, and Signal Evaluation Reports.
• Develop common practices, processes, templates, SOPs, monitoring tools, and innovative technology-enabled approaches to standardize Safety Sciences Delivery.
• Analyze aggregate safety data to identify emerging safety issues and patterns, and support benefit-risk assessments for periodic safety reports such as DSURs and PSURs.
• Collaborate with Safety Sciences Strategy and cross-functional partners in Clinical, Regulatory, Medical Affairs, Biostatistics, and Data Management.
• Build, coach, and scale a high-performing Safety Sciences team while driving leadership development, succession planning, and talent pipelines.

Requirements

• Advanced degree in life sciences or healthcare.
• 12+ years of pharmacovigilance experience, preferably with a focus on Safety Sciences and General Medicine.
• Strong knowledge of safety operations, regulatory compliance, quality management, and process optimization.
• Strong leadership, communication, organizational, workload planning, and multitasking skills.
• Experience overseeing operations in a global patient safety organization is preferred.
• Experience leading matrixed teams and managing people is preferred.

Nice to have

• Experience with AI technologies.
• Experience developing standardized training curricula, proficiency matrices, and knowledge management repositories.

Culture & Benefits

• Science-driven environment focused on developing life-changing medicines.
• Inclusive workplace and equal opportunity employment.
• Comprehensive rewards may include bonuses, equity awards, pension or retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during recruitment for applicants with qualifying disabilities or chronic illnesses.