Job Description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your role at Vantive

The Regional Head of Pharmacovigilance, Americas is responsible for providing strategic leadership and oversight of Pharmacovigilance activities across the Americas region, including the United States, Canada, Mexico, and Latin America. This role ensures compliance with global and local regulatory requirements, drives operational excellence, maintains inspection readiness, and advances patient safety initiatives in alignment with Vantive's Global Patient Safety (GPS) strategy.

The Regional Head of Pharmacovigilance, Americas is member of GPS PV LT and reports into the global head of GPS

What you’ll be doing

Strategic Pharmacovigilance Leadership

• Provides strategic direction, leadership, and accountability for Pharmacovigilance activities across the Americas region, ensuring alignment with corporate objectives, global patient safety strategies, and regional business priorities.

• Serves as a member of the Global Patient Safety Pharmacovigilance Leadership Team, contributing to the development and execution of global pharmacovigilance initiatives and organizational goals.

• Establishes a culture of quality, compliance, continuous improvement, and patient-centric decision-making across all regional Pharmacovigilance activities.

• Acts as the senior Pharmacovigilance representative for the Americas region, providing expert guidance on patient safety risks, benefit-risk considerations, and emerging regulatory requirements.

Regulatory Authority Engagement & Inspection Readiness

• Serves as the primary regional Pharmacovigilance representative in interactions with regulatory authorities across the Americas, including FDA, Health Canada, COFEPRIS, ANVISA, INVIMA, and other applicable health authorities.

• Leads regulatory inspections, health authority interactions, and internal audits, ensuring continuous inspection readiness throughout the region.

• Oversees the preparation, management, and successful closure of inspection observations, audit findings, and CAPAs in partnership with Global PV Compliance and other cross-functional stakeholders.

• Monitors evolving regulatory requirements and drives implementation of regulatory changes impacting regional Pharmacovigilance operations.

Regional Governance & Compliance

• Accountable for ensuring regional Pharmacovigilance activities remain compliant with applicable global and local regulations, industry standards, and company procedures.

• Establishes governance frameworks and performance monitoring mechanisms to ensure effective oversight of Pharmacovigilance activities across all regional markets.

• Maintains executive-level visibility of compliance performance, operational risks, inspection outcomes, and patient safety concerns.

• Ensures appropriate escalation and communication of emerging safety issues, benefit-risk concerns, and compliance risks to senior leadership and applicable subject matter experts.

Vendor & Alliance Oversight

• Owns governance and oversight of Pharmacovigilance service providers, distributors, and business partners responsible for delegated PV activities.

• Leads negotiation, implementation, and maintenance of Safety Data Exchange Agreements (SDEAs) and contractual Pharmacovigilance obligations with third parties across the region.

• Ensures effective vendor performance management through monitoring, compliance assessments, risk mitigation activities, and governance reviews.

People Leadership

• Leads, coaches, and develops a geographically dispersed Pharmacovigilance team across the Americas region.

• Accountable for talent acquisition, succession planning, employee development, performance management, and organizational capability building.

• Fosters a collaborative, inclusive, and high-performance culture focused on compliance, quality, and continuous learning.

Additional Regional Responsibilities

• Acts as the Local Qualified Person for Pharmacovigilance (LQPPV) for Vantive Mexico.

• Provides oversight of safety surveillance activities, literature monitoring, signal detection support, and local safety reporting processes.

• Ensures implementation and effectiveness of risk minimization measures and patient safety initiatives across regional markets.

• Supports crisis management activities related to patient safety issues and product-related safety concerns.

• Oversees the creation, implementation, and maintenance of local and regional Pharmacovigilance procedures and training programs.

• Drives continuous improvement initiatives to enhance compliance, efficiency, and effectiveness of regional Pharmacovigilance operations

What You'll Bring

• Degree in Health Sciences (pharmacist, physician, …) and minimum 5 years of working experience in Pharmacovigilance

• Minimum 3 years of people management experience

• Comprehensive understanding of pharmacovigilance regulations globally (FDA, Health Canada, Mexico HA,,) and international standards.

• Track-records working experience in PV at regional level or countries in a global organization setting.

• Ability to motivate, lead and develop people of diverse cultures and backgrounds.

• Mature personality with excellent leadership and interpersonal skills

  Demonstrated experience engaging directly with local regulatory authorities, leading inspections, audits, and regulatory responses.

• Experience managing outsourced Pharmacovigilance operations, vendors, and Safety Data Exchange Agreements (SDEAs).

• Strong strategic thinking, executive presence, stakeholder management, and influencing skills.

• Ability to operate effectively in a complex, matrixed global environment.

• Budget management and resource planning experience.

• Excellent verbal and written communication skills in English.

Reasonable Accommodation

Vantive 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 on the link here and let us know the nature of your request along with your contact information. Form Link

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