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 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

🎯 Exigences

• 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

🏖️ Avantages

• 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