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5 дней назад

Vice President and Global Head of Drug Safety and Pharmacovigilance

Формат работы
remote (Global)
Тип работы
fulltime
Грейд
head
Английский
b2
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
Vice President and Global Head of Drug Safety and Pharmacovigilance (Pharmacovigilance/Drug Safety): Setting the strategic direction for a global drug safety organization and transforming PV infrastructure, processes, and technology with an accent on safety surveillance, regulatory compliance, and medical oversight. Focus on leading global PV operations, implementing AI/ML-enabled workflows, managing FDA, EMA, and PMDA interactions, and building high-performing distributed teams.

Location: Fully remote; can be performed from anywhere. Frequent domestic and international travel of approximately 25% is expected for team meetings, events, and other business needs.

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

  • Set the strategic direction for the global Drug Safety and Pharmacovigilance organization and execute a multi-year PV roadmap.
  • Lead an enterprise-wide transformation of global PV infrastructure, processes, systems, and technology.
  • Oversee global safety surveillance, signal detection, risk management, medical safety deliverables, and benefit-risk communications.
  • Ensure pharmacovigilance compliance and inspection readiness across global markets, including FDA, EMA, and PMDA requirements.
  • Lead EMEA QPPV and Japan PV operations, REMS activities, global Risk Management Plans, and health authority interactions.
  • Build and develop a globally distributed PV organization while managing budgets, vendors, KPIs, and cross-functional partnerships.

Requirements

  • MD degree, 15+ years of drug development experience in a pharmaceutical or biotech company, and 10+ years of PV or drug safety leadership.
  • At least 5 years of experience as a VP or equivalent with full PV organizational accountability, plus 4+ years of post-doctoral clinical experience.
  • Experience leading a global PV organization, including safety strategy, compliance, operations, team performance, and organizational transformation.
  • FDA and EMA inspection leadership experience and experience as or supporting an EU/UK QPPV.
  • Experience with BLA, NDA, MAA, and JNDA submissions, health authority interactions, PV technology modernization, and AI/ML applications in pharmacovigilance.
  • Proficiency with ARISg, Oracle Argus, Veeva Vault Safety, MedDRA coding, and Microsoft Office Suite, along with strong executive leadership, communication, negotiation, and budget management skills.

Nice to have

  • Specialty Board Certification.
  • Advanced degree in Pharmaceutical Medicine, Epidemiology/Public Health, or Regulatory Science.
  • Rare disease experience.

Culture & Benefits

  • Fully remote work with purposeful in-person collaboration and support for flexible work schedules.
  • Medical, dental, vision, and mental health coverage, wellbeing reimbursement, and an Employee Assistance Program.
  • Paid time off, fertility and family-forming benefits, caregiver support, life and disability insurance, and a 401(k) plan with company matching.
  • Annual equity awards, Employee Stock Purchase Plan participation, learning programs, mentorship, and leadership development opportunities.
  • Employee resource groups, service programs, recognition initiatives, and opportunities to volunteer and give back.

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