Associate Pharmacovigilance Project Director – Delivery

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ERGOMED

WebsiteLinkedInAll Job Openings

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 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 activities, and planning • Attend client meetings as required and maintain an overview of client deliverables • Oversee client communications, project team training, and collaboration with relevant departments • 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 and advise clients on pharmacovigilance matters and regulatory changes • Provide appropriately qualified resources for effective project delivery • 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 preventive 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 within pharmacovigilance project management • Strong organizational 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 • Collaborative team environment • Supportive culture focused on kindness, flexibility, growth and belonging • Opportunity to contribute to patient safety and work with global teams