Associate Pharmacovigilance Project Director – Delivery

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

📋 Description

• Ensure that activities for contracted clients are executed within budget, on schedule, with high quality, and in accordance with relevant regulatory requirements.

• Serve as a pharmacovigilance expert, providing support to project teams throughout all contracted client activities.

• Assist department leaders and senior management with client-related tasks.

• Advocate for both client and PrimeVigilance interests while adhering to the agreed project scope.

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

• Maintain robust client relationships while consistently delivering high-quality work.

• Engage in the process of escalating issues as necessary.

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

• Manage project setup, ongoing maintenance, and activity scheduling.

• Attend client meetings as needed.

• Track client deliverables and tasks effectively.

• Manage client communications concerning any issues.

• Oversee the training of project teams.

• Coordinate with PrimeVigilance and client departments to fulfill contracted activities within agreed timelines and quality benchmarks.

• Ensure that departments and personnel are clear on the client and project scope.

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

• Guarantee that invoices are prepared and dispatched promptly.

• Assess project-specific analyses as required.

• Counsel clients on pharmacovigilance topics, including updates on regulatory and guidance changes.

• Provide suitably qualified resources for effective project management.

• Supervise client Quality Management System activities.

• Ensure adherence to applicable client quality standards.

• Comply with global pharmacovigilance regulatory obligations.

• Manage Quality Events and enact corrective and preventive measures.

• Participate in client audits and inspections.

⛳️ Requirements

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

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

• Prior experience in managing pharmacovigilance projects.

• Strong organizational skills, with a keen attention to detail and the ability to multitask.

• Effective management skills, encompassing time and issue management.

• Proficient conflict resolution skills.

• Strong decision-making capabilities.

• Ability to work collaboratively in a team setting.

• Capacity to motivate and mentor team members.

• Leadership abilities.

🏝️ Benefits

• Remote work options.

• Flexible work environment.

• Opportunities for professional growth.

• Collaborative team atmosphere.

• A culture of belonging and inclusiveness.

• Chance to collaborate with global teams.

• Work alongside specialists in clinical research, pharmacovigilance, and quality consulting.