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4 дня назад

Patient Safety Senior Manager (Pharmacovigilance)

Формат работы
remote (только Spain)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Spain
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
Patient Safety Senior Manager (Pharmacovigilance): Managing pharmacovigilance activities for marketed and investigational products with an accent on clinical trial safety, post-marketing surveillance, and regulatory compliance. Focus on medical review of safety data, aggregate safety reports, signal detection, and implementation of the Pharmacovigilance Quality Management System.

Location: Sant Feliu de Llobregat, Spain

Company

hirify.global develops medical dermatology products focused on addressing unmet patient needs through science, innovation, and care.

What you will do

  • Manage corporate pharmacovigilance activities for marketed and investigational products.
  • Provide operational and medical support for clinical trials, including SAE management, medical review, reconciliation, unblinding, and safety monitoring.
  • Lead the preparation and medical input of aggregate safety reports, including DSURs and other periodic regulatory submissions.
  • Review safety-related clinical documentation and lead the development of Safety Reporting Plans.
  • Support post-marketing surveillance, non-interventional studies, market research, registries, ICSR management, and safety data assessment.
  • Contribute to safety database activities, signal detection, PSUR and Risk Management Plan reviews, and the Pharmacovigilance Quality Management System.

Requirements

  • Medical science degree.
  • Experience in pharmacovigilance or clinical safety within a corporate setting.
  • Proficiency with safety databases.
  • Strong understanding of Good Pharmacovigilance Practices and applicable regulatory frameworks.
  • Postgraduate training in pharmacovigilance, clinical safety, or epidemiology is preferred.

Culture & Benefits

  • Work with global cross-functional teams across clinical development, post-marketing surveillance, and regulatory functions.
  • Environment focused on independent thinking, ownership, and meaningful impact on patient safety.
  • Recognised as a Top Employer in Spain since 2008 and in Germany since 2025.

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