Pharmacovigilance Project Manager
hace 4 días
**Company Description**
We are PrimeVigilance (part of Ergomed PLC), 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.
The PV Project Manager will be responsible for leading and managing long term engagements with our clients.
- 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.
- 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.
**Qualifications**
- Health Care Professional or Life Science Graduate
- 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
- 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.
**Additional Information**
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
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