3 часа назад
Executive Director, Global Pharmacovigilance Operations, Quality & Compliance
301 100 - 371 900$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Executive Director, Global Pharmacovigilance Operations, Quality & Compliance (Pharmacovigilance): Leading global pharmacovigilance operations, quality, compliance, vendor governance, and inspection readiness across clinical and marketed products with an accent on scalable PV systems, regulatory alignment, and operational performance. Focus on overseeing case processing, PSMF governance, GVP audits and inspections, CAPA management, safety agreements, and global team leadership.
Location: United States — Remote. Full-time work from home with occasional travel to offices or other locations, including national and international travel.
Annual salary: $301,100–$371,900 USD, plus eligibility for annual bonus and equity incentives.
Company
is a biopharmaceutical company developing medicines for rare diseases and supporting patients with life-changing treatments.
What you will do
- Lead and develop the Global Pharmacovigilance Operations, Quality & Compliance function and contribute to the global DSPV talent strategy.
- Oversee global PV operations, including intake, triage, case processing, quality control, regulatory reporting, reconciliation, and safety-information oversight.
- Maintain the global PV system, including policies, SOPs, process governance, training, PSMF oversight, and operational TMF support.
- Lead deviation and CAPA strategy, quality metrics, KPI development, effectiveness checks, and quality system management reporting.
- Direct vendor oversight, alliance management, safety agreements, PVAs, statements of work, and partner governance.
- Prepare for, lead, support, and respond to global regulatory authority audits and inspections.
Requirements
- Bachelor’s degree required; an advanced scientific or healthcare professional degree is preferred.
- At least 15 years of global full-life-cycle drug safety and pharmacovigilance experience across clinical development and post-marketing activities.
- Leadership experience with global teams, including direct and matrix leadership, performance management, and talent development.
- Direct experience in PV operations, vendor and alliance management, GVP quality management, compliance, and inspection readiness.
- Strong knowledge of global PV regulations, GVP, FDA, EMA, ICH guidance, and international safety requirements.
- Working knowledge of safety databases, Veeva Vault eTMF or comparable TMF systems, MedDRA, and WHO Drug dictionaries.
Nice to have
- Healthcare professional degree such as PharmD, RPh, RN/BSN, or MPH.
- Rare disease experience.
- Experience supporting commercialization, product launches, portfolio growth, and regional expansion.
Culture & Benefits
- Remote-first work model with occasional business travel.
- Vacation time and company-observed public holidays.
- Volunteer days and employee wellbeing benefits.
- Long-term incentives, employee stock purchase plans or equivalent offerings, and fitness reimbursement.
- Tuition sponsorship and professional development plans.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
4 часа назад
Associate Clinical Safety Surveillance Director (Pharmacovigilance)
3 дня назад
Medical Director, Drug Safety and Pharmacovigilance
268 000 - 331 000$
1 день назад
Vice President Drug Safety (Pharmacovigilance)
405 000 - 430 000$
6 часов назад
Executive Director, Global Safety Strategy & Benefit Risk Management (Pharmacovigilance)
275 000 - 375 000$
4 дня назад
Executive Medical Director, Pharmacovigilance Risk Management (PVRM)
355 000 - 504 000$
6 дней назад