обновлено 1 день назад
Vice President Drug Safety (Pharmacovigilance)
405 000 - 430 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Vice President Drug Safety (Pharmacovigilance): Leading drug safety operations across Catalyst’s clinical development and commercial portfolio with an accent on PV infrastructure, regulatory reporting, signal detection, and compliance. Focus on designing safety strategies, overseeing inspections and vendors, and managing multidisciplinary pharmacovigilance teams across the product lifecycle.
Location: Fully remote within the United States; travel to company headquarters and other locations is required as needed. Authority to work in the United States is required.
Salary: $405,000–$430,000 per year
Company
is a biopharmaceutical company developing and commercializing therapies, including treatments for rare diseases.
What you will do
- Develop and execute the strategic vision for the drug safety function across clinical and commercial programs.
- Lead pharmacovigilance operations, including safety data collection, evaluation, analysis, surveillance, and signal detection.
- Oversee expedited and periodic safety reports, benefit-risk assessments, risk management strategies, and regulatory submissions.
- Provide drug safety expertise during health authority interactions, inspections, audits, regulatory responses, and scientific advice meetings.
- Manage PV specialists, external vendors, safety databases, MedDRA updates, systems, budgets, and service-level governance.
- Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Legal, IT, and Commercial teams across product lifecycles.
Requirements
- MD in a relevant clinical or scientific field.
- At least 15 years of pharmacovigilance experience in the biopharmaceutical industry, including 10 years in senior leadership or management roles.
- Experience leading safety operations across clinical development and post-marketing, including regulatory reporting, compliance, surveillance, and signal detection.
- Deep knowledge of GCP and pharmacovigilance regulations and expectations, including FDA, EMA, and ICH requirements.
- Experience with safety databases and pharmacovigilance systems such as ARGUS.
- Must have authority to work in the United States and be willing to travel as needed.
Nice to have
- Experience with rare diseases and/or neuromuscular diseases.
- Experience in a fast-paced biotechnology environment.
Culture & Benefits
- Fully remote work with travel required to support business operations.
- Health, dental, and vision insurance.
- Generous paid time off.
- Retirement savings plan with company match.
- Collaborative, cross-functional environment focused on quality, compliance, and continuous improvement.
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