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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.

• 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 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, please speak to the recruiter if you decide to apply and are selected for an interview.

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 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.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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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.

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