5 дней назад
Director, Global Patient Safety Sciences Delivery - Rare Disease
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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