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5 дней назад

Director, Global Patient Safety Sciences Delivery - Rare Disease

Формат работы
hybrid
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
Ireland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Director, Global Patient Safety Sciences Delivery - Rare Disease (Pharmacovigilance): Leading safety surveillance, signal management, aggregate reporting, and compliant safety operations for a rare disease portfolio with an accent on standardization, quality management, and cross-functional delivery. Focus on analyzing aggregate safety data, coordinating Safety Monitoring Teams and Signal Evaluation Reports, and building a high-performing Safety Sciences team.

Location: Dublin, Ireland; hybrid schedule with 3 days per week onsite and 25% travel may be required

Company

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

What you will do

  • Lead safety data processing, submission creation, documentation, safety surveillance, signal management, and aggregate reporting across the Rare Disease portfolio.
  • Coordinate signal detection and management activities, including Safety Monitoring Teams, Safety Surveillance Plans, and Signal Evaluation Reports.
  • Develop standardized practices, processes, templates, SOPs, monitoring tools, and training programs for Safety Sciences Delivery.
  • Analyze aggregate safety data to identify emerging safety issues and patterns, partnering with Safety Sciences Strategy.
  • Coordinate cross-functional delivery of benefit-risk assessments for periodic safety reports, including DSURs and PSURs.
  • Build, coach, and scale a high-performing Safety Scientists team while driving succession planning and talent development.

Requirements

  • Advanced degree in life sciences or healthcare.
  • 12+ years of pharmacovigilance experience, preferably focused on Safety Sciences and rare diseases.
  • Experience managing complex operations, ensuring regulatory compliance, and optimizing safety processes.
  • Strong leadership, communication, organizational, workload planning, and project management skills.
  • Experience in a global patient safety organization, matrixed environments, and people management is preferred.
  • Experience with AI technologies is preferred.

Culture & Benefits

  • Science-driven organization focused on developing life-changing medicines.
  • Inclusive workplace and equal opportunity employment.
  • Competitive total rewards package that may include bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
  • Background checks may be conducted in accordance with the laws of the country where the position is based.

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