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6 дней назад

Pharmacovigilance QA Auditor Specialist

79 000 - 127 650$
Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
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
Pharmacovigilance QA Auditor Specialist (Pharmacovigilance and Quality Assurance): Planning, conducting, and reporting internal and external pharmacovigilance audits with an accent on audit compliance, data analysis, and business partner collaboration. Focus on supporting regulatory inspections, evaluating GxP and non-regulated processes, and resolving complex compliance issues.

Location: Hybrid position based in Raritan, NJ; Titusville, NJ; or Horsham, PA, United States. Requires 25% domestic and/or international travel.

Salary: $79,000–$127,650 annually

Company

Johnson & Johnson MedTech develops healthcare and medical solutions, alongside Innovative Medicine products designed to improve patient outcomes.

What you will do

  • Lead the planning, execution, and reporting of routine internal and external pharmacovigilance audits.
  • Support audits of data, internal facilities, and processes in GxP and non-regulated areas.
  • Support regulatory inspections in various roles.
  • Consult with business partners on routine compliance tasks and inquiries.
  • Collaborate on complex compliance issues and help establish unified departmental positions.
  • Participate in assigned projects and prepare training materials when needed.

Requirements

  • Bachelor’s degree required; a life science, natural science, or computer science degree is preferred.
  • At least 4 years of relevant pharmacovigilance experience.
  • Strong project management, verbal and written communication, and presentation skills.
  • Strong teamwork, collaboration, data analysis, critical thinking, and attention to detail.
  • Experience with Microsoft Outlook, PowerPoint, Excel, and Word.
  • Availability to work in the listed United States locations and travel 25% domestically and/or internationally.

Nice to have

  • Broad understanding of auditing processes and the audit landscape.
  • Experience with various audit types.

Culture & Benefits

  • Inclusive work environment guided by the company’s Credo.
  • Retirement pension and 401(k) savings plans.
  • Vacation, sick time, holiday pay, and personal and family time.
  • Parental, bereavement, caregiver, volunteer, and military spouse leave programs.

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