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11 дней назад

Manager/Sr. Manager, Drug Safety & PV

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Japan
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
Manager/Sr. Manager, Drug Safety & PV (pharmacovigilance): Managing individual case safety reports, safety databases, aggregate reports, and regulatory submissions for investigational and marketed products with an accent on safety data review, process improvement, and PV quality activities. Focus on J-DSUR and J-RMP reporting, Argus and E2B R3 case management, inspection readiness, CAPA processes, and compliance with FDA, EU, and ICH requirements.

Location: Tokyo, Japan, based out of the Tokyo office with weekly flexibility in a hybrid work environment. Occasional domestic and international travel of approximately 10% is required.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

  • Manage individual case safety report activities, including case receipt, processing, medical review, regulatory submission, and safety database maintenance.
  • Lead local aggregate safety reporting, including J-DSUR and J-RMP-related activities, and ensure regulatory documents are submitted on time.
  • Review and analyze ongoing safety data for investigational and marketed products.
  • Improve pharmacovigilance processes by developing procedures, templates, tracking tools, reports, and compliance plans.
  • Support regulatory inquiry responses and participate in global PV and joint safety meetings with partners.
  • Coordinate PV inspection readiness, deviations, CAPAs, effectiveness checks, training, self-inspections, and PV agreements.

Requirements

  • At least five years of drug safety or pharmacovigilance experience in the pharmaceutical industry, covering investigational and marketed products.
  • At least two years of experience with local aggregate safety reporting and J-RMP.
  • Working knowledge of FDA, EU, ICH, ICH/CIOMS, GCP, and clinical trial safety reporting requirements.
  • Experience with Argus safety database, E2B R3, MedDRA, and case report management processes.
  • Bachelor's, master's, or doctoral degree in pharmacy, nursing, healthcare, or life sciences.
  • Ability to read and collate scientific and medical literature.

Nice to have

  • Master's degree in Public Health or an MBA.

Culture & Benefits

  • Hybrid work environment with weekly flexibility and technology supporting collaboration across locations and time zones.
  • Flexible working hours and vacation programs supporting work-life balance.
  • Retirement benefits, equity compensation, and participation opportunities in the employee stock purchase plan.
  • Internal and external training, LinkedIn Learning, specialized professional training, and AI-enabled learning tools.
  • Global recognition programs and employee resource group activities.

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