Director, Business and Process Optimization – Pharmacovigilance

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🕒 vor 22 Tagen

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Vollzeit

🔴 Experte

👔 Direktor

👻 Geisterscore 16%

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• Seit 23 Tagen offen.
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ERGOMED

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 1997

💼 Beratung

🏥 Gesundheitswesen

📦 Logistik

Consulting • Healthcare • Logistics

ERGOMED ist eine weltweit tätige Unternehmensgruppe, die spezialisierte Dienstleistungen für die Biotechnologie- und Pharmaindustrie erbringt. Sie ist in verschiedenen Geschäftsbereichen aktiv, darunter Ergomed Clinical Research, PrimeVigilance und ADAMAS Consulting, und bietet als Clinical Research Organization (CRO) umfassende Full-Service-Fähigkeiten. Mit Fokus auf Onkologie, seltene Erkrankungen und komplexe Studien bietet Ergomed zudem End-to-End-Pharmakovigilanz- und Medical-Information-Services sowie umfassende GxP-Audits. Ergomed unterstützt die Arzneimittelentwicklung mit einer globalen Präsenz in rund 100 Ländern.

Beschreibung

• Provide strategic leadership for departmental operations and resourcing • Develop and implement strategic business plans with senior leadership • Oversee cross-functional activities, projects and initiatives • Deliver strategic insights, analyses and recommendations for continuous process improvement • Assess compliance with cross-functional processes, systems, applications, training and communications • Lead large, complex, cross-functional process improvement initiatives • Collaborate with stakeholders, peers and leaders on strategy, execution and communications planning • Provide administrative oversight of staffing, budgeting, scheduling and long-term planning • Direct staff through line management and oversee recruitment, induction, talent development and retention • Provide coaching, feedback, performance appraisals, development plans and career coaching • Develop business plans and forecasts • Support and drive process and systems optimization • Oversee or respond to client and internal process audits and CAPAs • Cultivate a continuous improvement environment • Act as an internal transformation consultant for M&A integration activities

🎯 Anforderungen

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • Extensive pharmacovigilance experience • Experience with process improvement, safety applications and systems • Demonstrated line management experience • Extensive leadership experience in pharmacovigilance from a service provider environment • Experience optimizing processes and managing through to implementation • Outstanding leadership and management skills • Advanced skill in process development and improvement, especially as it applies to clinical and post-marketing pharmacovigilance • Excellent project management skills • Superior attention to detail, investigative and analytical skills • Outstanding interpersonal, negotiation and problem solving skills • Superior computer skills, including understanding of clinical management and pharmacovigilance technology and systems • Expert understanding of clinical trial practices, processes and requirements, including regulatory guidelines and directives • Superior oral and written communication skills • Ability to communicate in English, both orally and in writing • Ability to work in a multidisciplinary and/or multicultural team setting • Ability to drive innovation in process improvements • Outstanding organizational, judgment, analytical, decision-making and interpersonal skills • Certification in process improvement methodologies such as Lean Six Sigma is a plus

🏖️ Vorteile

• Flexible work arrangements • Growth opportunities • Collaborative and supportive work environment • Diverse and inclusive workplace • Global team and international exposure • Opportunity to contribute to patient safety and pharmaceutical treatments

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