PV Risk Management Specialist

Baxter International Inc.

. Serve as the primary author of Pharmacovigilance Risk Management Plans (PV-RMPs) using global, regional, and local templates .

Posted 9/18/2026full-timeRemote • Illinois • United StatesJuniorMid-Level💰 $112,000 - $154,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in authoring Pharmacovigilance Risk Management Plans (PV-RMPs) while ensuring compliance with regulatory requirements. Possesses strong project management, analytical, and communication skills to effectively lead cross-functional teams and interact with regulatory authorities.

Highest-signal resume keywords

Pharmacovigilance Risk Management Plans (PV-RMPs)Regulatory ComplianceProject ManagementAnalytical SkillsTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceRisk Management Plans (RMPs)EU Risk Management PlansRegulatory Submission RequirementsScientific Knowledge

Soft Skills

Interpersonal CommunicationCritical ThinkingFacilitation SkillsMentoring

Industry Keywords

Pharmaceutical IndustryRegulatory Authority InteractionHealth Authority InquiriesCross-Functional CollaborationRisk Minimization Measures

About the role

Key responsibilities & impact

Serve as the primary author of Pharmacovigilance Risk Management Plans (PV-RMPs) using global, regional, and local templates
Ensure 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

Requirements

What you’ll need

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)
Experience authoring EU Risk Management Plans (RMPs)
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
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
Applicants must be authorized to work for any employer in the U.S.
Employment visa sponsorship is unavailable

Benefits

Comp & perks

Medical and dental coverage starting on day one
Basic life insurance
Accident insurance
Short-term disability insurance
Long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP) with ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP) with employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits
Discretionary bonuses may be available