Remote Pharmacovigilance Risk Manager

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

Job summary

Baxter in the United States is seeking a Pharmacovigilance Risk Management Specialist to lead PV-RMP development and maintain plans to support the safe use of our products worldwide. You will work with cross-functional and global partners to ensure risk management strategies meet regulatory requirements and translate safety data into clear documentation.

In this role you will contribute to timely PV-RMP submissions, mentor team members, and support global regulatory objectives, advancing patient

Qualifications

• Bachelor's degree in Nursing or related field.
• 2+ years in Pharmacovigilance or related functions.
• 2-3 years of PV-RMP authoring experience.

Responsibilities

• Author PV-RMPs using global/regional templates and regulatory requirements.
• Coordinate cross-functional review and approval of PV-RMPs.
• Respond to regulatory authority questions and commitments for PV-RMP submissions.
• Independently manage timelines, deliverables and submission activities.
• Represent PV Risk Management on cross-functional teams and strategy discussions.
• Collaborate with country affiliates and global stakeholders on PV-RMPs and commitments.
• Support implementation of risk minimization measures and PV activities.
• Mentor and onboard new PV Risk Management team members.

Skills

Pharmacovigilance

Regulatory writing

Project management

Cross-functional collaboration

Scientific writing

Regulatory affairs

Education

Bachelor's degree in Nursing or related field

Job description

Baxter in the United States is seeking a Pharmacovigilance Risk Management Specialist to lead PV-RMP development and maintain plans to support the safe use of our products worldwide. You will work with cross-functional and global partners to ensure risk management strategies meet regulatory requirements and translate safety data into clear documentation.

In this role you will contribute to timely PV-RMP submissions, mentor team members, and support global regulatory objectives, advancing patient