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14 часов назад

PV Risk Management Specialist (Pharmacovigilance)

112 000 - 154 000$
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
PV Risk Management Specialist (Pharmacovigilance): Developing and maintaining Pharmacovigilance Risk Management Plans for Baxter products worldwide with an accent on regulatory compliance, scientific analysis, and cross-functional coordination. Focus on authoring EU and global RMPs, responding to health authority inquiries, managing submission deliverables, and implementing risk minimization measures.

Location: Deerfield, Illinois, United States

Salary: $112,000–$154,000 annually, plus potential discretionary bonuses

Company

hirify.global develops healthcare products and solutions guided by a mission to save and sustain lives.

What you will do

  • Author Pharmacovigilance Risk Management Plans (PV-RMPs) using global, regional, and local templates.
  • Coordinate cross-functional review, feedback, approval, and submission activities.
  • Respond to regulatory authority questions, requests, and commitments related to PV-RMP submissions.
  • Manage project timelines, deliverables, and risk management plan activities.
  • Represent Pharmacovigilance Risk Management in cross-functional teams and strategic safety discussions.
  • Support risk minimization measures and mentor new team members.

Requirements

  • Bachelor’s degree in Nursing, Biological Sciences, Medical, Clinical, or a related field.
  • At least two years of pharmaceutical industry experience in Pharmacovigilance, Medical Affairs, Clinical, or related functions.
  • Two to three years of experience authoring PV-RMPs, including EU Risk Management Plans.
  • Knowledge of European Union and global pharmacovigilance regulations and regulatory submission requirements.
  • Strong analytical, critical thinking, project management, communication, and technical writing skills.
  • Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

  • Advanced degree or clinical practice experience.
  • Experience with non-EU PV-RMPs, generic EU submissions, or risk minimization activities.

Culture & Benefits

  • Culture centered on courage, trust, collaboration, ownership, and accountability.
  • Medical and dental coverage starting on the first day.
  • Life, accident, disability, and business travel accident insurance.
  • 401(k) retirement plan, company stock purchase plan, flexible spending accounts, and educational assistance.
  • Paid holidays, paid time off of 20–35 days based on length of service, family and medical leave, and paid parental leave.

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