Remote Pharmacovigilance Risk Management Specialist

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

Benefits offered by this job

Health and dental coverage from day 1

401(k) plan with company match

Stock Purchase Plan (ESPP)

Paid holidays & PTO

Job summary

BAXTER in Joliet, IL, is seeking a Pharmacovigilance Risk Management Specialist to lead PV-RMP development worldwide, translating safety data into clear risk management documentation and ensuring regulatory submissions meet health authority requirements.

You will author PV-RMPs, coordinate cross-functional reviews, respond to authority inquiries, manage timelines, and mentor team members while collaborating with global partners to advance patient safety.

Qualifications

• Minimum two years of pharmaceutical industry experience in Pharmacovigilance, Medical Affairs, Clinical, or related functions.
• Two to three years of experience authoring PV-RMPs.
• Experience authoring EU Risk Management Plans (RMPs) and knowledge of European Union pharmacovigilance requirements.
• Knowledge of global PV-RMP regulations and regulatory submission requirements.
• Experience interacting with regulatory authorities and addressing health authority inquiries.
• Strong analytical, critical thinking, and project management skills.
• Excellent written, verbal, and interpersonal communication skills, including the ability to facilitate cross-functional discussions.

Responsibilities

• Serve as the primary author of 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.

Skills

Strong writing skills

Analytical thinking

Project management

Cross-functional collaboration

Excellent communication

Education

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

Advanced degree or clinical practice experience

Job description

BAXTER in Joliet, IL, is seeking a Pharmacovigilance Risk Management Specialist to lead PV-RMP development worldwide, translating safety data into clear risk management documentation and ensuring regulatory submissions meet health authority requirements.

You will author PV-RMPs, coordinate cross-functional reviews, respond to authority inquiries, manage timelines, and mentor team members while collaborating with global partners to advance patient safety.