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6 дней назад

Associate Director, PV Operations, PV Center of Excellence (AI)

142 500 - 256 500$
Формат работы
hybrid
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
Associate Director, PV Operations, PV Center of Excellence (AI): Supporting and strengthening Moderna’s pharmacovigilance quality management system across commercial programs, affiliate operations, regulatory intelligence, and inspection readiness with an accent on compliance, standardization, and patient safety. Focus on implementing AI-enabled pharmacovigilance solutions, managing business continuity and regulatory risks, and designing controls and processes across global geographies.

Location: Cambridge, Massachusetts, United States; 70% in-office and 30% flexible. Only U.S. persons are eligible due to U.S. export-control requirements.

Salary: $142,500–$256,500 annually, with potential bonus, incentive compensation, or equity awards.

Company

hirify.global develops mRNA medicines and technology platforms designed to transform how medicines are created and delivered.

What you will do

  • Manage pharmacovigilance frameworks for commercial programs, affiliate operations, country operations, and inspection readiness.
  • Establish PV standards, governance, KPIs, compliance controls, and operational processes across geographies.
  • Lead business continuity planning, testing, and ongoing risk-management activities.
  • Monitor global PV regulatory developments and integrate requirements into procedures, systems, and operational controls.
  • Lead digital and AI-enabled pharmacovigilance initiatives, including social media monitoring and adverse-event identification.
  • Partner with Pharmacovigilance, Quality, Regulatory Sciences, Clinical Development, Medical Affairs, Commercial, Digital, and regional stakeholders to improve compliance and patient safety.

Requirements

  • Bachelor’s degree, preferably in a science or health-related field; a master’s degree is preferred.
  • At least 7 years of pharmacovigilance experience, including commercial products or affiliate PV operations.
  • Strong knowledge of global PV regulations, regulatory intelligence, PV systems, and compliance procedures.
  • Experience with health authority inspection preparation, interviews, responses, and inspection management.
  • Strong communication, influencing, stakeholder management, analytical, negotiation, and conflict-management skills.
  • Ability to manage multiple complex projects in a fast-paced environment.

Nice to have

  • Experience with commercial PV programs, governance, controls, and compliance mechanisms.
  • Familiarity with digital, automation, or AI-enabled pharmacovigilance, including social media monitoring.
  • Master’s degree in a science or health-related field.

Culture & Benefits

  • 70/30 in-office working model focused on collaboration, mentorship, and innovation.
  • Healthcare and voluntary benefits, plus fitness, mindfulness, and mental health resources.
  • Family planning support, including fertility, adoption, and surrogacy benefits.
  • Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
  • Savings and investment programs, along with location-specific benefits.

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