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.
Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader
Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management
Role and Responsibilities
Providing support to other activities undertaken by the project team on behalf of the client and the company
Line Manages assigned ICSR staff
Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency)
Proposes process changes to ICSR Operational Lead
Manages ICSR deviations with ICSR Operational Lead support
Reviews trackers and timesheet data and ensures accuracy
Is involved in ICSR processing and 2nd QC of cases
Operates as the assigned team SME and supports other SMEs
Excellent communication (written and verbal) skills
Organization skills, including attention to details and multitasking
Delegation skills
Planning and time management
Technical skills
Team working
Fluency in English and Japanese
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:
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!
We look forward to welcoming your application.
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