Pharmacovigilance Project Manager

Job Description

• PrimeVigilance is continuing to expand and is looking for an experienced Pharmacovigilance (PV) Project Manager to join our dynamic, rapidly expanding organisation.
• Based in any of our offices, the PV Project Manager will be responsible for leading and managing long term engagements with our clients.
• Experienced home-based project managers will also be considered.
• Reference: I6qUQcK4k0i9nfxejLB0V8yVE6vQcPJC4gd7iVR0Nmnr53bYpqf8JpQBO0Or9hOU

Key Responsibilities

• Representing the client's interest with the aim of achieving client´s goals and objectives and the Prime Vigilance’s interest with the aim of keeping the agreed project scope.
• Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance.
• Management of client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations.
• Acting as the primary contact point for project-related matters for both the client and PrimeVigilance staff.
• Project activities planning.
• Coordinating the colleagues working on a project.
• Maintenance of project-specific RAM (Responsibility Assignment Matrix).
• Assurance, that all PV Division staff is familiar with the client and the project scope.
• Assurance of training of all team members from relevant quality documents, including project-specific documentation.
• Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones.
• Making sure that all the outputs are delivered in high quality and before the final deadline set up by client.
• Reporting the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.
• Preparation of Accounting of Services and invoice, if delegated.
• Keeping of an oversight on all communication with client.
• Making sure that quality standards applicable to the respective client are met.
• Having an overview of all SOPs relevant to the respective client.
• Monitoring of compliance results and proposing corrective and preventive actions, where necessary. Preparation of Deviation reports.
• Acting as audit/inspection coordinator, if applicable.
• Proposing processes improvements.
• Leading by example.
• Proper hand-over of all open issues, ongoing project tasks and upcoming milestones and deadlines before his/her absence to project manager deputy.

Qualifications

• Proven track record in Pharmacovigilance activities as well as project management experience.
• Additional information
• All your information will be kept confidential according to EEO guidelines.