Associate Pharmacovigilance Project Director – Delivery

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

📋 Description

• Ensure that all contracted client activities are executed within budget, on schedule, with high quality, and in accordance with regulatory standards.

• Provide expertise in pharmacovigilance to support project teams.

• Assist the Head of Project Management, Head of PV Operations, and senior leadership in activities related to clients.

• Act as a representative for both the client and PrimeVigilance while upholding the agreed-upon project scope.

• Supervise modifications to project scope, timelines, and costs.

• Maintain robust client relationships and uphold consistently high standards of work.

• Engage in processes for escalating issues.

• Comprehend client pharmacovigilance needs and ensure that services effectively meet them.

• Oversee project setup, plan maintenance activities, and facilitate client meetings.

• Retain an overview of client deliverables and participate in client-related tasks.

• Manage client communications concerning issues.

• Oversee training for project team members.

• Coordinate with PrimeVigilance and client departments to guarantee high-quality and timely delivery.

• Ensure that personnel are well-acquainted with the client and project scope.

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

• Make sure invoices are generated and dispatched punctually.

• Review project-specific analyses as required.

• Provide clients with guidance on pharmacovigilance matters, including changes in regulations and guidelines.

• Supply appropriately qualified resources for effective project management.

• Oversee activities related to the client Quality Management System.

• Ensure that applicable client quality standards are adhered to.

• Guarantee compliance with global pharmacovigilance regulatory requirements.

• Manage Quality Events and implement corrective and preventive actions (CAPA).

• Take part in client audits and inspections.

⛳️ Requirements

• Exceptional written and verbal communication skills for both client-facing and internal interactions.

• Diverse experience in pharmacovigilance within a CRO setting.

• Prior experience in pharmacovigilance project management.

• Strong organizational skills, meticulous attention to detail, and the ability to juggle multiple tasks.

• Management abilities, including time and issue management.

• Skills in conflict resolution.

• Strong decision-making capabilities.

• Ability to work effectively in a team setting.

• Capacity to motivate and coach team members.

• Leadership qualities.

🏝️ Benefits

• Opportunity for remote work.

• A flexible work environment.

• Opportunities for professional growth.

• A collaborative and supportive team culture.

• An inclusive workplace that fosters belonging.

• Chance to work with global teams.

• Focus on initiatives that help safeguard patients.

• Join a passionate and collaborative team of experts.