Associate Pharmacovigilance Project Director – Delivery

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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

• Ensure all contracted client activities are delivered within budget, on time, with good quality, and in compliance with regulatory requirements • Support project teams as a pharmacovigilance expert • Support the Head of Project Management, Head of PV Operations, and senior leadership in client-related activities • Represent client and PrimeVigilance interests while maintaining agreed project scope • Oversee changes to project scope, schedule, and costs • Maintain strong client relations and consistently high-quality work • Participate in issue escalation processes • Understand client pharmacovigilance requirements and ensure services address them • Oversee project setup, maintenance activity planning, and client meetings • Maintain an overview of client deliverables and participate in tasks delivered to clients • Oversee client communications regarding issues • Oversee project team training • Coordinate with PrimeVigilance and client departments to ensure high-quality, timely delivery • Ensure personnel are familiar with the client and project scope • Review client-specific core documents, including joint operational guidelines and safety management plans • Ensure invoices are prepared and sent on time • Review project-specific analyses as needed • Advise clients on pharmacovigilance matters, including regulatory and guidance changes • Provide appropriately qualified resources for effective project management • Oversee client Quality Management System activities • Ensure applicable client quality standards are met • Ensure compliance with worldwide pharmacovigilance regulatory obligations • Manage Quality Events and implement corrective and preventative actions (CAPA) • Participate in client audits and inspections

🎯 Anforderungen

• Excellent client-facing and internal written and verbal communication skills • Varied pharmacovigilance experience in a CRO • Previous experience within pharmacovigilance project management • Strong organization skills, attention to detail, and ability to multitask • Management skills, including time and issue management • Conflict resolution skills • Decision-making skills • Team-working skills • Ability to motivate and coach people • Leadership skills

🏖️ Vorteile

• Remote work • Flexible work environment • Growth opportunities • Collaborative and supportive team culture • Belonging and inclusive workplace • Opportunity to work with global teams • Work focused on helping protect patients • Passionate and collaborative team of experts