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 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

🎯 Exigences

• 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

🏖️ Avantages

• 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