Associate Pharmacovigilance Project Director – Delivery

This is a fully remote position, open to applicants in Europe.

📋 Description

• Ensure that client activities under contract are executed within budget, on schedule, with high quality, and in adherence to relevant regulatory standards.

• Provide expertise in pharmacovigilance to support project teams.

• Assist department heads and senior management with client-related initiatives.

• Represent both the client and PrimeVigilance interests while upholding the agreed-upon project parameters.

• Supervise modifications to project scope, timeline, and budget.

• Foster strong client relationships and deliver consistently high-quality work.

• Engage in the escalation of issues as necessary.

• Comprehend client pharmacovigilance needs and ensure that services meet those requirements.

• Oversee project initiation, maintenance planning, client meetings, and deliverables.

• Manage client communications and training for project teams.

• Collaborate with PrimeVigilance and client departments to ensure timely and quality delivery of contracted activities.

• Ensure team members understand the client and project scope thoroughly.

• Review client-specific foundational documents, such as joint operational guidelines and safety management plans.

• Confirm that invoices are prepared and dispatched punctually.

• Assess project-specific analyses.

• Counsel clients on pharmacovigilance issues, including changes in regulations and guidance.

• Provide suitably qualified resources for effective project management.

• Supervise client Quality Management System activities.

• Ensure that applicable client quality standards are adhered to.

• Guarantee compliance with global pharmacovigilance regulatory requirements.

• Manage Quality Events and implement corrective and preventive measures.

• Participate in client audits and inspections.

⛳️ Requirements

• Outstanding written and verbal communication skills, both client-facing and internal.

• Diverse experience in pharmacovigilance within a Contract Research Organization (CRO).

• Prior experience in managing pharmacovigilance projects.

• Strong organizational skills, meticulous attention to detail, and the ability to multitask.

• Management capabilities, including time and issue management.

• Skills in conflict resolution.

• Strong decision-making abilities.

• Ability to work effectively in a team environment.

• Capacity to motivate and mentor individuals.

• Leadership qualities.

🏝️ Benefits

• Work remotely.

• Enjoy a flexible work environment.

• Opportunities for professional growth.

• Be part of a supportive and collaborative culture.

• Experience a workplace that values belonging and inclusivity.

• Join a passionate team of experts in clinical research, pharmacovigilance, and quality consulting.