Global PV Risk Manager — Strategic Pharmacovigilance

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

Benefits offered by this job

Sign-on bonus

Day-one health coverage

401(k) with company match

Employee stock purchase plan

Job summary

Baxter is seeking a Pharmacovigilance Risk Management Specialist to lead the development and maintenance of PV-RMPs that support safe use of our products worldwide. You will work with cross-functional and global partners to ensure risk management strategies and regulatory submissions meet health authority requirements.

This role leverages your scientific expertise, writing skills, and attention to detail to translate safety data into clear PV-RMP documentation, contribute to timely high-quality

Qualifications

• Bachelor’s degree in Nursing, Biological Sciences, Medical, Clinical, or related field.
• Minimum two years of pharmaceutical industry experience in Pharmacovigilance, Medical Affairs, Clinical, or related functions.
• Two to three years of experience authoring PV-RMPs.
• Advanced degree or EU PV experience preferred.
• Experience authoring EU RMPs and knowledge of EU 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.
• Experience interacting with regulatory authorities.
• $5,000 sign‑on bonus offered for this role.

Responsibilities

• Author PV-RMPs using global, regional, and local templates while ensuring regulatory compliance.
• Lead 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 timelines, deliverables, and submission activities for risk management plans.
• Represent Pharmacovigilance Risk Management on cross-functional teams and contribute to safety discussions.
• Collaborate with country affiliates and global stakeholders to develop PV-RMPs and associated commitments.
• Support implementation and management of risk minimization measures and related pharmacovigilance activities.
• Mentor and train new Pharmacovigilance Risk Management team members.

Skills

Analytical skills

Project management

Written communication

Cross-functional teamwork

Regulatory writing

Regulatory awareness

Education

Bachelor’s degree in a related field

Advanced degree preferred

Job description

Baxter is seeking a Pharmacovigilance Risk Management Specialist to lead the development and maintenance of PV-RMPs that support safe use of our products worldwide. You will work with cross-functional and global partners to ensure risk management strategies and regulatory submissions meet health authority requirements.

This role leverages your scientific expertise, writing skills, and attention to detail to translate safety data into clear PV-RMP documentation, contribute to timely high-quality