Vaccines Safety Sciences Lead (Pharmacovigilance)

Location: King of Prussia, Pennsylvania, United States

Company

hirify.global is a global biotherapeutics company developing and delivering therapies across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas.

What you will do

• Lead pharmacovigilance functions, aggregate safety reporting, and compliance with national and international regulations and GxP guidelines.
• Monitor evolving pharmacovigilance legislation and direct implementation of changes across the global PV system.
• Establish and maintain regulatory documents, including the Pharmacovigilance System Master File.
• Lead signal detection, safety data analysis, advanced analytical outputs, and data visualization for global decision-making.
• Support regulatory pharmacovigilance inspections, audits, safety reports, product labeling, and investigator communications.
• Translate business and user requirements into technical solutions, improve processes, and provide management support to direct reports.

Requirements

• Bachelor’s degree in a life science, medical documentation, science, medicine, health sciences, or epidemiology; alternatively, a relevant master’s degree or equivalent qualification.
• 8–10 years of pharmacovigilance experience in the multinational pharmaceutical industry.
• 6 or more years of leadership experience.
• Expert knowledge of national and international pharmacovigilance regulations and PV processes.
• Experience with regulatory inspections, complex data sets, GxP, relevant software applications, CAPA project management, and SOP development.
• Knowledge of privacy protection legislation, IT standards, and other relevant regulations.

Culture & Benefits

• Benefits information is provided through CSL’s employee well-being program.
• Inclusive and belonging-focused workplace centered on curiosity, empathy, and diversity.
• Work supporting therapies for patients in more than 100 countries.