PV Risk Management Specialist

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

This is whereyour work makes a difference.

At the company, 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 the company 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 the company

As aPharmacovigilance Risk Management Specialist, you will lead the development and maintenance of Pharmacovigilance Risk Management Plans (PV-RMPs) that support the safe use of the company 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 the company'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.

We understand compensation is an important factor as you consider the next step in your career. At the company, 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 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at the company (except for Puerto Rico)

This is where your well-being matters. the company offers comprehensive compensation and benefits packages for eligible roles. 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.

Equal Employment Opportunity

the company is an equal opportunity employer. the company 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.

Reasonable Accommodations

the company 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.

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