Remote PV Leader, Pharmacovigilance

Worldwide; North Carolina; Teletrabalho; USD 90 000 - 178 000; Tempo integral

Resumo da oferta

Worldwide Clinical Trials is seeking a Manager, Pharmacovigilance (US) to lead PV activities across multiple trials in a remote US setting. You will guide teams, ensure patient safety and regulatory compliance, and drive on-time study outcomes while mentoring staff and collaborating with cross-functional partners.

Ideal candidates have 5+ years of global PV experience, strong PV regulations knowledge, and demonstrated leadership in mentorship or people development.

Qualificações

• Bachelor’s degree in a science-related field, nursing, or equivalent.
• Minimum 5 years of global pharmacovigilance experience across multiple phases.
• At least 2 years in mentorship or people development.
• Strong knowledge of PV regulations and regulatory reporting.
• Experience with safety databases and data extraction.
• Excellent communication and stakeholder management in a matrix environment.

Responsabilidades

• Lead pharmacovigilance projects and ensure compliance with regulations, SOPs and requirements.
• Manage delivery to quality, timeline, and budget, escalating risks when needed.
• Coach, mentor, and develop direct reports for accountability and growth.
• Provide guidance on safety regulations, reporting requirements, and PV practices.
• Monitor scope and resources, supporting operational efficiency.
• Support recruitment, onboarding, training, and knowledge sharing.
• Contribute to proposals, budget discussions, and SOP development.
• Represent PV during sponsor audits and assist senior PV leadership as needed.
• Participate in initiatives to enhance operational excellence and service delivery.

Conhecimentos

Pharmacovigilance leadership

Global PV experience

Regulatory knowledge

Regulatory reporting

Project management

Stakeholder management

English fluency

Formação académica

Bachelor’s degree in science or nursing

Ferramentas

MS Office (Excel, Word, PowerPoint)

Descrição da oferta de emprego

Worldwide Clinical Trials is seeking a Manager, Pharmacovigilance (US) to lead PV activities across multiple trials in a remote US setting. You will guide teams, ensure patient safety and regulatory compliance, and drive on-time study outcomes while mentoring staff and collaborating with cross-functional partners.

Ideal candidates have 5+ years of global PV experience, strong PV regulations knowledge, and demonstrated leadership in mentorship or people development.