Associate Pharmacovigilance Project Director – Delivery

Job not on LinkedIn

🔥 2 hours ago

🇪🇺 Europe – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Logo of ERGOMED

ERGOMED

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Ensure contracted client activities are delivered within budget, on time, with high 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 client relationships and oversee issue escalation • Understand client pharmacovigilance requirements and ensure services address them • Oversee project setup, maintenance planning, client meetings, and client deliverables • Oversee client communications and 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 and guidance changes • Provide appropriately qualified project resources • Oversee Quality Management System activities and ensure client quality standards are met • Ensure compliance with worldwide pharmacovigilance regulatory obligations • Manage Quality Events and implement corrective and preventative actions • Participate in client audits and inspections

🎯 Requirements

• Excellent client-facing and internal written and verbal communication skills • Varied pharmacovigilance experience in a CRO • Previous experience in pharmacovigilance project management • 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

🏖️ Benefits

• Remote work • Flexible work environment • Growth opportunities • Supportive and collaborative culture • Global team environment • Belonging and inclusive workplace • Opportunity to work with experts in clinical research, pharmacovigilance, and quality consulting

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