Global Pharmacovigilance Risk Manager (PV-RMP)

BAXTER; Deerfield (IL); Presencial; USD 112.000 - 154.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

401(k) plan with company match

Employee stock purchase plan

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

PV risk management

PV-RMP authoring

Regulatory coordination

Project management

Technical writing

Cross-functional collaboration

Educación

Bachelor's degree in Nursing

Advanced degree or clinical experience (preferred)

Descripción del empleo

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.