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1 месяц назад

Regional Head of Pharmacovigilance, Americas

Формат работы
onsite
Тип работы
fulltime
Грейд
head
Английский
b2
Страна
Mexico
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
Regional Head of Pharmacovigilance, Americas (Patient Safety): Providing strategic leadership and oversight for pharmacovigilance activities across the Americas with an accent on regulatory compliance, inspection readiness, and patient safety initiatives. Focus on leading health authority interactions and audits, governing vendors and Safety Data Exchange Agreements, and developing a geographically dispersed regional team.

Location: Mexico City, Mexico

Company

hirify.global develops vital organ therapies, digital solutions, and advanced services, with a longstanding focus on kidney care and dialysis.

What you will do

  • Provide strategic leadership and accountability for pharmacovigilance activities across the Americas, including the United States, Canada, Mexico, and Latin America.
  • Represent regional pharmacovigilance activities before health authorities, lead inspections and audits, and oversee responses, findings, and CAPAs.
  • Establish regional governance, compliance monitoring, risk escalation, and inspection-readiness frameworks.
  • Oversee pharmacovigilance vendors, distributors, business partners, and Safety Data Exchange Agreements.
  • Lead, coach, and develop a geographically dispersed pharmacovigilance team, including talent planning and performance management.
  • Act as the Local Qualified Person for Pharmacovigilance for hirify.global Mexico and oversee safety surveillance, reporting, risk minimization, procedures, and training.

Requirements

  • Degree in health sciences, such as pharmacy or medicine.
  • At least 5 years of pharmacovigilance experience and at least 3 years of people management experience.
  • Experience with global pharmacovigilance regulations and authorities including FDA, Health Canada, and Mexican health authorities.
  • Regional pharmacovigilance experience in a global organization, including direct regulatory engagement, inspections, audits, and regulatory responses.
  • Experience managing outsourced pharmacovigilance operations, vendors, and Safety Data Exchange Agreements.
  • Strong strategic thinking, executive presence, stakeholder management, communication, budget management, and resource planning skills; excellent English required.

Culture & Benefits

  • Work within a global patient safety organization focused on compliance, quality, continuous improvement, and patient-centered decision-making.
  • Collaborate across a complex, matrixed global environment and with diverse cultures and backgrounds.
  • Reasonable accommodations are available throughout the application and interview process.

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