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 good quality, and in compliance with applicable regulatory requirements • Support project teams as a pharmacovigilance expert across contracted client activities • Provide support to department heads and senior leadership on 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, and activity planning • Attend client meetings as required • Monitor client deliverables and tasks • Oversee client communications regarding issues • Oversee training of project teams • Coordinate with PrimeVigilance and client departments to deliver contracted activities to agreed timelines and quality standards • Ensure departments and personnel understand 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 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 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 • Collaborative team environment • Belonging and inclusive culture • Opportunity to work with global teams • Work alongside experts in clinical research, pharmacovigilance, and quality consulting