PV Risk Management Specialist

Baxter Healthcare; Deerfield (IL); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Health benefits

401(k) plan with company match

Employee stock purchase plan

Job summary

Baxter Healthcare in Deerfield, IL is seeking a Pharmacovigilance Risk Management Specialist to lead the development and maintenance of PV-RMPs worldwide, ensuring regulatory compliance and clear risk communication. You will work with cross-functional teams to deliver high-quality risk management documentation and support regulatory submissions.

Ideal candidates bring 2+ years in Pharmacovigilance or related fields, experience authoring PV-RMPs, and strong writing and project-management skills.

Qualifications

• Bachelor’s degree in Nursing, Biological Sciences, Medical, Clinical, or related field.
• Two years of pharmaceutical industry experience in Pharmacovigilance or related functions.
• Two to three years of PV-RMP authoring experience.
• Experience with EU PV-RMPs and global PV-RMP regulations is a plus.

Responsibilities

• Author PV-RMPs using global/regional templates and ensure regulatory compliance.
• Coordinate cross-functional review and approval processes for PV-RMPs.
• Respond to regulatory authority questions related to PV-RMP submissions.
• Manage timelines, deliverables, and submission activities for risk management plans.
• Represent PV Risk Management in cross-functional teams and strategic safety discussions.
• Collaborate with country affiliates and global stakeholders on PV-RMPs and commitments.
• Support implementation of risk minimization measures and related activities.
• Mentor junior team members.

Skills

PV risk management

PV-RMP authoring

Regulatory coordination

Project management

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Nursing

Advanced degree or clinical experience (preferred)

Job description

This is whereyour 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

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 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.

We understand compensation is an important factor as you consider the next step in your career. 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 on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits.

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 Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter 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 on 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. For additional information regarding Baxter US Benefits, refer to our Benefits site: Benefits | 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 the link here and let us know the nature of your request along with your contact information.

1 Baxter Parkway|Deerfield, IL 60015|United States of America