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3 часа назад

Executive Director, Global Pharmacovigilance Operations, Quality & Compliance

301 100 - 371 900$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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 hirify.global 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

hirify.global 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.

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