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Baxter International

Global provider of medical care products

Global PV Risk Management Partner

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRemote

About the Job

Requirements

  • A bachelor's degree in Nursing, Biological Sciences, Medical, Clinical, or a related field is required.
  • At least two years of pharmaceutical industry experience in Pharmacovigilance, Medical Affairs, Clinical, or related functions is required.
  • Two to three years of experience authoring Pharmacovigilance Risk Management Plans (PV-RMPs) is required.
  • Experience authoring EU Risk Management Plans (RMPs) and knowledge of European Union pharmacovigilance requirements are required.
  • Knowledge of global PV-RMP regulations and regulatory submission requirements is required.
  • Strong analytical, critical thinking, and project management skills are required.
  • Strong technical writing capabilities and scientific or clinical knowledge are required.
  • Experience interacting with regulatory authorities and addressing health authority inquiries is required.
  • Applicants must be authorized to work for any employer in the United States; employment visa sponsorship or sponsorship takeover is not available.

Responsibilities

  • Serve as the primary author of Pharmacovigilance Risk Management Plans (PV-RMPs), using global, regional, and local templates while ensuring compliance with applicable regulatory requirements.
  • Lead and coordinate cross-functional review, feedback, and approval processes for PV-RMPs.
  • Respond to regulatory authority questions, requests, and commitments related to PV-RMP submissions.
  • Independently manage project timelines, deliverables, and submission activities associated with risk management plans.
  • Represent Pharmacovigilance Risk Management on cross-functional teams and contribute to strategic safety discussions.
  • Partner with country affiliates and global stakeholders to develop, maintain, and complete PV-RMPs and associated risk management commitments.
  • Support implementation and management of risk minimization measures and related pharmacovigilance activities.
  • Mentor and support training and onboarding of new Pharmacovigilance Risk Management team members.

Desired Qualifications

  • An advanced degree is preferred.
  • Clinical practice experience is preferred.
  • Experience with non-EU PV-RMPs is preferred.
  • Experience with generic EU submissions is preferred.
  • Experience with risk minimization activities is preferred.

About the Company

Baxter International

Global provider of medical care products

Baxter International develops and manufactures medical products and equipment for hospitals and blood banks. Its products include sterile IV solutions and blood storage containers; innovations like the Transfuso-Vac extended blood shelf life, and a plastic blood bag helped shape modern blood banking. The company differs from competitors through a long track record of sterile manufacturing, blood-storage innovations, and strategic mergers that broaden its product portfolio. Its goal is to provide reliable, safe medical products that support patient care and hospital operations worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Deerfield, IL
Founded
1931

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