Associate Pharmacovigilance Project Director – Delivery

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ERGOMED

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1997

💼 Conseil

🏥 Santé

📦 Logistique

Consulting • Healthcare • Logistics

ERGOMED est un groupe international qui fournit des services spécialisés aux industries biotechnologique et pharmaceutique. Il opère à travers plusieurs lignes de services, notamment Ergomed Clinical Research, PrimeVigilance et ADAMAS Consulting, et se consacre à offrir des capacités complètes de CRO (Contract Research Organization). Axé sur l’oncologie, les maladies rares et les essais complexes, il propose également des services de pharmacovigilance et d’information médicale de bout en bout, ainsi que des audits GxP complets. Ergomed s’engage à accompagner le développement de médicaments, avec une présence mondiale dans une centaine de pays environ.

Description

• Ensure all contracted client activities are delivered within budget, on time, with good quality, and in compliance with regulatory requirements • Support project teams as a pharmacovigilance expert • Support the Head of Project Management, Head of PV Operations, and senior leadership in 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 activity planning, and client meetings • Maintain an overview of client deliverables and participate in tasks delivered to clients • Oversee client communications regarding issues • Oversee project team training • Coordinate with PrimeVigilance and client departments to ensure high-quality, timely delivery • Ensure personnel are familiar with 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 preventative actions (CAPA) • Participate in client audits and inspections

🎯 Exigences

• 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, attention to detail, and ability to multitask • Management skills, including time and issue management • Conflict resolution skills • Decision-making skills • Team-working skills • Ability to motivate and coach people • Leadership skills

🏖️ Avantages

• Remote work • Flexible work environment • Growth opportunities • Collaborative and supportive team culture • Belonging and inclusive workplace • Opportunity to work with global teams • Work focused on helping protect patients • Passionate and collaborative team of experts