Manager, Pharmacovigilance

🕒 vor 3 Tagen

🌲 North Carolina – Remote

infoinfo

💵 $90.000 - $178.000 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👔 Manager

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Worldwide Clinical Trials ist eine globale Auftragsforschungsorganisation (CRO) und bietet umfassende Dienstleistungen für klinische Studien. Das Unternehmen ist auf die Unterstützung von Studien in verschiedenen Therapiegebieten wie Onkologie, Kardiologie und seltenen Erkrankungen spezialisiert. Mit über 30 Jahren Erfahrung legt Worldwide Clinical Trials Wert auf persönliche Betreuung und maßgeschneiderte Lösungen über den gesamten Lebenszyklus der Arzneimittelentwicklung hinweg. Zum Serviceportfolio zählen unter anderem klinisches Monitoring, Data Management, Patient Recruitment sowie Regulatory Consulting – für Präzision und individuelle Aufmerksamkeit in jeder klinischen Studie.

Beschreibung

• Lead and oversee pharmacovigilance projects and team operations to ensure compliance with applicable regulations, guidelines, and internal processes • Manage project delivery against agreed timelines, quality expectations, and budgeted scope of work • Coach, mentor, and develop team members • Identify, escalate, and help resolve study, operational, or staff-related issues • Maintain expertise in global safety regulations, reporting requirements, and pharmacovigilance best practices • Support project planning, including scope management, proposal reviews, budget discussions, and bid defense participation • Organize and deliver training initiatives • Contribute to staff recruitment, onboarding, and professional development • Represent Pharmacovigilance during sponsor audits • Contribute to departmental or company-wide initiatives • Provide leadership support and serve as backup to senior pharmacovigilance leadership

🎯 Anforderungen

• 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 or people leadership capacity • Strong knowledge of clinical trial safety processes, pharmacovigilance regulations, regulatory reporting requirements, SOPs, and industry best practices • Excellent understanding of medical and scientific terminology, adverse event assessment, and safety database technologies • Proven ability to manage multiple priorities, work independently, and collaborate effectively within matrixed global teams • Strong interpersonal, presentation, and stakeholder management skills, with experience engaging sponsors, clients, and cross-functional colleagues • Proficiency in written and verbal English • Excellent communication, organizational, and attention-to-detail skills

🏖️ Vorteile

• Competitive benefits package depending on location • Inclusive and equitable workplace • Professional growth and development opportunities • Training and professional development initiatives

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