Principal/Senior Pharmacovigilance Project Manager

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider 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 has become one of the global leaders in its field. We cover all therapy areas including medical device. 

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. 

• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget, and are on time with good quality and in compliance with the applicable regulatory requirements.
• Providing support to Director of Projects and senior leadership management, as applicable, inother activities undertaken on behalf of the client and the company.
• Acting as the primary contact point for project-related matters 
• Workflow management, KPI/metric reporting
• Manage changes to the project scope, project schedule and project costs, as applicable
• Maintaining good client relations and ensuring a consistently high quality of work for each client
• Understand client PV requirements and ensure service provided addresses all requirements
• Project set-up and maintenance activities planning; Organising/chairing and attending regular client meetings
• Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones
•  Assurance of training of all team members from relevant quality documents, including project-specific documentation
• Close cooperation with other Primevigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines 
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
• Preparation of client specific core documents (e.g. Join operational guidelines, Safety management plan, Monthly reports, etc), as applicable
• Preparation of invoices, project financial analysis
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
• Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines, maintaining compliance with the PV system and providing PV training, as required

• Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of ICSRs, writing, or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs 
• PV Project Management experience from ideally a service provide / CRO 
• Health Care Professional or Life Science Graduate 
• Be comfortable with communicating at senior levels within pharmaceutical organizations 
• Have good leadership qualities including skills in planning, mentoring, meeting facilitation, communication and problem solving. 

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  

We look forward to welcoming your application.