Associate Pharmacovigilance Project Director – Delivery

Job not on LinkedIn

🔥 2 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 the Head of Project Management, Head of Pharmacovigilance Operations, and senior leadership on client 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, deliverables, and client meetings • Oversee client communications and project team training • Coordinate with PrimeVigilance and client departments to deliver contracted activities on time and to quality standards • Review client-specific core documents • Ensure invoices are prepared and sent on time • Review project-specific analyses • Advise clients on pharmacovigilance matters, including regulatory changes • Provide appropriately qualified project resources • Oversee Quality Management System activities • Ensure client quality standards and worldwide pharmacovigilance regulatory obligations are met • 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 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 and supportive team culture • Belonging and inclusive workplace • Opportunity to work with global experts in clinical research, pharmacovigilance, and quality consulting