PV Risk Management Specialist

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 As a   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.

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.

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