PV Risk Management Specialist

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

Benefits offered by this job

Health insurance

Dental coverage

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid holidays and paid time off (20–35

days

Job summary

Baxter International is seeking a Pharmacovigilance Risk Management Specialist to develop and maintain PV-RMPs, ensuring regulatory compliance and timely submissions. You’ll work with global partners to translate safety data into clear risk management documentation and support regulatory objectives for Baxter products worldwide.

The role emphasizes strong scientific writing, attention to detail, and collaboration across functions to drive patient safety and regulatory success.

Qualifications

• Bachelor’s degree in a life sciences field.
• Minimum two years of pharmaceutical industry PV/related experience.
• Two to three years of PV-RMP authoring experience.
• Knowledge of EU PV-RMPs and global PV regulations preferred.

Responsibilities

• Author PV-RMPs using global/regional/local templates and compliant with regulations.
• Lead cross-functional reviews, feedback, and approvals for PV-RMPs.
• Respond to regulatory authority questions on PV-RMP submissions.
• Manage timelines, deliverables, and submission activities for risk plans.
• Represent PV Risk Management on cross-functional teams and strategic safety discussions.
• Collaborate with country affiliates and global stakeholders to maintain PV-RMPs.
• Support risk minimization activities and training for the team.

Skills

PV risk management

Regulatory submissions

Cross-functional collaboration

Technical writing

Regulatory knowledge

Education

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

2+ years pharma PV/Medical Affairs/Clinical experience

PV-RMP authoring experience (2–3 years)

Advanced degree or EU PV experience preferred

Job description

This is where your work makes a difference. At Baxter, we believe every person - regardless of who they are or where they are from - deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter

Pharmacovigilance Risk Management Specialist

You will lead the development and maintenance of Pharmacovigilance Risk Management Plans (PV-RMPs) that support the safe use of Baxter products worldwide. Working closely with cross-functional and global partners, you will help ensure risk management strategies and regulatory submissions meet applicable health authority requirements. This is where your scientific expertise, strong writing skills, and attention to detail help translate complex safety data into clear, effective risk management documentation. In this role, you'll contribute to the timely delivery of high-quality PV-RMPs, support global regulatory objectives, and help advance Baxter's commitment to patient safety.

What you'll be doing

• Serve as the primary author of Pharmacovigilance Risk Management Plans (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.

What you'll bring

• 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.

By staying current on regulatory developments and industry trends, you will ensure that Baxter remains compliant.

Compensation

At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

US Benefits at Baxter (except for Puerto Rico)

Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.

Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.

Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

Join us and enjoy the competitive compensation and benefits we offer to our employees.

Baxter Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.