7 часов назад
Executive Director, Global Safety Strategy & Benefit Risk Management (Pharmacovigilance)
275 000 - 375 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Executive Director, Global Safety Strategy & Benefit Risk Management (Pharmacovigilance): Leading global safety strategy, benefit-risk assessment, pharmacovigilance, and safety governance across a pulmonary pharmaceutical portfolio with an accent on clinical medicine, regulatory science, and evidence-based safety decisions. Focus on overseeing signal evaluation, regulatory submissions, inspection readiness, cross-functional governance, and the development of AI- and analytics-enabled safety capabilities.
Location: Hybrid from the RTP, North Carolina office or remote within the continental United States; relocation assistance may be available for non-local candidates. Travel may reach 15%.
Salary: $275,000–$375,000 per year.
Company
is a publicly traded biotech and pharmaceutical company developing therapies for rare diseases and technologies intended to expand the availability of transplantable organs.
What you will do
- Develop and execute global safety strategy for investigational and marketed products across the pulmonary portfolio.
- Lead benefit-risk assessments, safety surveillance, signal evaluation, risk minimization, and pharmacovigilance strategy.
- Oversee safety governance committees and align patient safety decisions across clinical development, regulatory, medical, quality, commercial, legal, and business development functions.
- Provide strategic leadership and oversight to Brand Safety Leads and Medical Safety Physicians.
- Represent Global Patient Safety in regulatory interactions, inspections, submissions, approvals, and lifecycle management.
- Drive innovation through AI, advanced analytics, automation, and modern safety science methodologies.
Requirements
- MD degree.
- 10+ years of experience leading a safety risk management organization in pharma or biopharma.
- 3+ years managing other MDs or sub-investigators.
- 5+ years supporting clinical trials as a principal investigator, sub-investigator, or development team member.
- Experience with data analytics tools including Excel, patient listing reviews, dashboards, Spotfire, or QlikView.
- Ability to work from the continental United States; excellent communication skills are required for health authority interactions.
Nice to have
- MD specialization in pulmonology, US practice experience, and board certification.
- 3+ years of clinical or medical practice experience in the United States or full registration with a medical licensing body.
- US state medical licensure.
Culture & Benefits
- Mission-driven work focused on unmet medical needs and rare, life-threatening diseases.
- Medical, dental, vision, and prescription coverage.
- Wellness resources, 401(k), and ESPP savings plans.
- Paid time off, paid parental leave, and disability benefits.
- Opportunities to present safety posters, white papers, and other publications at medical conferences.
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