Manager, Pharmacovigilance

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $90k - $178k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Lead and oversee pharmacovigilance projects and teams in compliance with regulations, SOPs, and project requirements • Manage project delivery against quality, timeline, and budget expectations; identify and escalate risks or issues • Coach, mentor, and develop direct reports • Provide guidance on safety regulations, reporting requirements, and pharmacovigilance best practices • Monitor project scope and resource requirements, escalating changes and supporting operational efficiency • Support recruitment, onboarding, training, and knowledge-sharing initiatives • Contribute to proposal reviews, budget discussions, bid defense meetings, and SOP development • Represent Pharmacovigilance during sponsor audits and back up senior PV leadership • Participate in departmental and company-wide operational excellence initiatives

🎯 Requirements

• Bachelor’s degree in a science-related field, nursing, or an equivalent combination of education and relevant experience • Minimum 5 years of global pharmacovigilance experience supporting pre-approval clinical trials across multiple phases and therapeutic areas • At least 2 years in a mentorship, supervisory, or people-development capacity • Strong knowledge of pharmacovigilance regulations, adverse event assessment, regulatory reporting requirements, SOPs, and accepted clinical trial practices • Experience working with safety databases, data extraction processes, and Microsoft Office applications, including Excel, Word, and PowerPoint • Ability to manage multiple priorities, work independently, and collaborate effectively within a matrix environment • Strong interpersonal, presentation, and stakeholder management skills with experience interacting with sponsors, clients, and cross-functional teams • Fluency in written and verbal English