Associate Pharmacovigilance Project Director – Delivery

Job not on LinkedIn

🔥 33 minutes ago

🇪🇺 Europe – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 16%

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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 good quality, and in compliance with applicable regulatory requirements • Support project teams as a pharmacovigilance expert • Support the Head of Project Management, Head of PV Operations, and senior leadership • 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, and client meetings • Maintain an overview of client deliverables and oversee client communications • Oversee training of project teams • Coordinate with PrimeVigilance and client departments to deliver contracted activities within timelines • Ensure departments and 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 client quality standards are met • Ensure compliance with worldwide pharmacovigilance regulatory obligations • Manage quality events and implement corrective and preventive actions (CAPA) • Participate in client audits and inspections

🎯 Requirements

• Excellent client-facing and internal communication (written and verbal) skills • Varied pharmacovigilance experience in a CRO • Previous experience within 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 • Collaborative team environment • Flexible culture • Growth opportunities • Supportive workplace focused on kindness, flexibility, growth and belonging

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