Remote Pharmacovigilance Risk Management Lead

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

Benefits offered by this job

Health insurance

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter is seeking a Pharmacovigilance Risk Management Specialist to lead PV-RMP development and regulatory submissions worldwide. You will work with global partners to ensure risk management strategies meet health authority requirements and translate safety data into clear documentation.

The role emphasizes scientific writing, project management, and collaboration across clinical, pharmacovigilance, and regulatory teams to deliver timely PV-RMPs and support patient safety initiatives.

Qualifications

• Two to three years of experience authoring PV-RMPs.
• Experience with EU PV-RMPs and EU risk management requirements.
• Knowledge of global PV-RMP regulations and regulatory submission requirements.
• Strong analytical and writing abilities.
• Experience interacting with regulatory authorities.
• Excellent communication and project management skills.

Responsibilities

• Act as primary author of PV-RMPs using global/regional templates.
• Lead cross-functional review, feedback, and approval processes.
• Respond to regulatory authority questions and commitments.
• Manage timelines, deliverables, and submission activities.
• Represent PV-RMP on cross-functional teams and strategy discussions.
• Collaborate with country affiliates and global stakeholders on PV-RMPs.

Skills

PV-RMP authoring

Regulatory submissions

Cross-functional leadership

Project management

Scientific writing

Regulatory affairs

Education

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

Job description

Baxter is seeking a Pharmacovigilance Risk Management Specialist to lead PV-RMP development and regulatory submissions worldwide. You will work with global partners to ensure risk management strategies meet health authority requirements and translate safety data into clear documentation.

The role emphasizes scientific writing, project management, and collaboration across clinical, pharmacovigilance, and regulatory teams to deliver timely PV-RMPs and support patient safety initiatives.