Global Pharmacovigilance Risk Management Lead

BAXTER; Chicago (IL); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Sign-on bonus $5,000

Job summary

BAXTER is seeking a Pharmacovigilance Risk Management Specialist to lead the development and maintenance of PV-RMPs, ensuring global safety and regulatory compliance across products. You will partner with cross-functional and country affiliates to deliver high-quality risk management documentation.

You will author PV-RMPs, manage timelines, respond to authorities, mentor teammates, and support risk minimization activities while advancing patient safety and regulatory objectives worldwide.

Qualifications

• Bachelor’s degree in Nursing, Biological Sciences, Medical, Clinical, or a related field.
• Minimum two years of pharmaceutical industry experience in Pharmacovigilance, Medical Affairs, Clinical, or related functions.
• Two to three years of experience authoring Pharmacovigilance Risk Management Plans (PV-RMPs).
• Advanced degree, clinical practice experience, experience with non-EU PV-RMPs, generic EU submissions, or risk minimization activities are preferred.
• Experience authoring EU Risk Management Plans (RMPs) and knowledge of European Union pharmacovigilance requirements.
• Knowledge of global PV-RMP regulations and regulatory submission requirements.
• Strong analytical, critical thinking, and project management skills.
• Excellent written, verbal, and interpersonal communication skills, including the ability to facilitate cross-functional discussions.
• Scientific or clinical knowledge with strong technical writing capabilities.
• Experience interacting with regulatory authorities and addressing health authority inquiries.
• $5,000 sign‑on bonus offered for this role.

Responsibilities

• Lead the development and maintenance of PV-RMPs using global, regional, and local templates.
• Coordinate cross-functional review, feedback, and approval processes for PV-RMPs.
• Respond to regulatory authority questions and commitments related to PV-RMP submissions.
• Independently manage timelines, deliverables, and submission activities for risk management plans.
• Represent PV-RMP on cross-functional teams and contribute to strategic safety discussions.
• Partner with country affiliates and global stakeholders to develop, maintain PV-RMPs and related commitments.
• Support implementation and management of risk minimization measures and related activities.
• Mentor and train new Pharmacovigilance Risk Management team members.

Skills

Regulatory writing

Project management

Cross-functional collaboration

Verbal communication

Education

Bachelor’s degree in Nursing, Biological Sciences, Medical, Clinical, or related field

Job description

BAXTER is seeking a Pharmacovigilance Risk Management Specialist to lead the development and maintenance of PV-RMPs, ensuring global safety and regulatory compliance across products. You will partner with cross-functional and country affiliates to deliver high-quality risk management documentation.

You will author PV-RMPs, manage timelines, respond to authorities, mentor teammates, and support risk minimization activities while advancing patient safety and regulatory objectives worldwide.