8 дней назад
Director, Safety Scientist Lead - Rare Disease
205 000 - 341 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Safety Scientist Lead - Rare Disease (Pharmacovigilance): Leading safety data processing, signal management, aggregate reporting, and compliant safety surveillance for a rare disease portfolio with an accent on operational standardization, regulatory quality, 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: Tarrytown, New York, United States; 4 days per week on site. Travel of up to 25% may be required.
Salary: $205,000–$341,600 annually
Company
is a biotechnology company that invents, develops, and commercializes medicines for serious diseases, including rare diseases.
What you will do
- Lead Rare Disease safety data processing, submission creation, documentation, safety surveillance, signal management, and aggregate reporting.
- 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, training curricula, and knowledge-management resources.
- Analyze aggregate safety data to identify emerging safety issues and patterns.
- Coordinate benefit-risk assessments for periodic safety reports and contribute to global patient safety documents.
- Build, coach, and scale a high-performing Safety Sciences team while driving succession planning and leadership development.
Requirements
- Advanced degree in life sciences or healthcare.
- 12+ years of pharmacovigilance experience, preferably in Safety Sciences and Rare Disease.
- Experience ensuring compliant, high-quality execution of safety operations and regulatory activities.
- Strong leadership, communication, organizational, workload-planning, and project-management skills.
- Experience with global patient safety operations, matrixed collaboration, and people management is preferred.
Nice to have
- Experience with AI technologies.
- Experience overseeing operations within a global patient safety organization.
- Experience leading matrixed roles across multiple organizational functions.
Culture & Benefits
- Science-driven environment focused on developing life-changing medicines.
- Inclusive workplace with equal employment opportunity and reasonable accommodations where required.
- Comprehensive rewards may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
- Many roles are performed onsite to support collaboration.
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