We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives. 

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.

Office locations include - UK: Guildford, US: Boston, Cary, Germany: Frankfurt, Koln, Netherlands: Amsterdam, Poland: Krakow, Croatia: Zagreb, Czech Republic: Prague, Serbia: Belgrade.   

Experienced home-based project managers will also be considered.

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.

• Life Science degree 
• Proven track record in a wide variety of Pharmacovigilance activities as well as project management experience
• Experience with budgets/accounting/bid defenses is desirable 
• Motivated attitude 
• Must be able to work well in a team 

Why PrimeVigilance?  

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.   

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.  

We offer:  

• Training and career development opportunities internally   
• Strong emphasis on personal and professional growth  
• Friendly, supportive working environment  
• Opportunity to work with colleagues based all over the world, with English as the company language  

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!   

• Quality  
• Integrity & Trust   
• Drive & Passion   
• Agility & Responsiveness   
• Belonging  
• Collaborative Partnerships