Associate Pharmacovigilance Project Director – Delivery

Stelle nicht auf LinkedIn

🔥 vor 1 Stunde

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mail-Benachrichtigung für neue Jobs einrichten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

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 contracted client activities are delivered within budget, on time, with good quality, and in compliance with applicable regulatory requirements • Support project teams as a pharmacovigilance expert • Support department heads and senior leadership in client and company 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 planning, client meetings, deliverables, and client task execution • Oversee communications with clients • Oversee project team training • Coordinate with PrimeVigilance and client departments to ensure timely, high-quality delivery • Ensure personnel understand the client and project scope • Review client-specific core documents • Ensure invoices are prepared and sent on time • Review project-specific analyses • Advise clients on pharmacovigilance matters, including regulatory or guidance changes • Provide appropriately qualified resources for effective project management • Oversee Quality Management System activities • Ensure applicable client quality standards are met • Ensure compliance with worldwide pharmacovigilance regulatory obligations • Manage Quality Events and implement 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 pharmacovigilance project management experience • Project organization skills, including attention to detail and multitasking • 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 culture • Belonging and inclusive workplace • Global team exposure • Passionate and collaborative team of experts