Associate Pharmacovigilance Project Director – Delivery

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

📋 Description

• Ensure that client activities outlined in contracts are delivered within budget, on schedule, with high quality, and in compliance with relevant regulatory standards.

• Provide support to project teams by acting as a pharmacovigilance expert.

• Assist the Head of Project Management, Head of PV Operations, and senior leadership in their initiatives.

• Represent the interests of both the client and PrimeVigilance while adhering to the agreed project scope.

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

• Foster strong client relationships while consistently delivering high-quality results.

• Engage in the processes for escalating issues as necessary.

• Comprehend client pharmacovigilance requirements and ensure that services effectively address them.

• Oversee the setup of projects, planning for maintenance, and facilitating client meetings.

• Maintain a comprehensive overview of client deliverables and manage client communications.

• Supervise the training of project teams.

• Collaborate with PrimeVigilance and client departments to ensure contracted activities are delivered within set timelines.

• Ensure that departments and personnel are aware of the client and project scope.

• Review core documents specific to the client.

• Guarantee that invoices are prepared and dispatched promptly.

• Assess project-specific analyses.

• Provide advice to clients on pharmacovigilance issues, including updates on regulatory or guidance changes.

• Ensure the availability of suitably qualified resources for effective project management.

• Oversee activities related to the quality management system.

• Confirm that client quality standards are upheld.

• Ensure compliance with global pharmacovigilance regulatory requirements.

• Manage quality events and implement corrective and preventive actions (CAPA).

• Participate in client audits and inspections.

⛳️ Requirements

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

• Diverse experience in pharmacovigilance within a CRO setting.

• Prior experience in pharmacovigilance project management.

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

• Effective management skills, encompassing time and issue management.

• Proficient conflict resolution abilities.

• Strong decision-making capabilities.

• Collaborative team-working skills.

• Ability to inspire and coach team members.

• Leadership qualities.

🏝️ Benefits

• Remote work options.

• A collaborative team environment.

• A flexible cultural approach.

• Opportunities for growth and development.

• A supportive workplace that emphasizes kindness, flexibility, growth, and a sense of belonging.