Full TimeENNorth America
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.
Summary
· Assures and exerts activities leading to effective work in the area of ICSR Management
· Supports the ICSR Management Unit in administrative tasks, tracking, storing, planning
· May be involved in processing of simple and standardised form ICSRs, following appropriate
training
Roles and Responsibilities:
Receiving and returning safety messages and acknowledge receipt, tracking and filing of
Individual Case Safety Reports (ICSRs) and/or requests for followup in compliance with applicable regulations, PrimeVigilance
procedures and in accordance with client specific requirements and timelines
· Perform other miscellaneous administrative tasks, as applicable
· Performing activities in the scope of ICSR management unit within agreed extent and timeframe
(including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) that require simple processing (e.g.
solicited cases with limited information, minimal information reports, E2B cases without
narrative writing, data clean-up activities and standardised form reports) from all
sources in compliance with applicable regulations, PrimeVigilance procedures and in
accordance with client specific requirements and timelines
High school or university graduate.
Experience desirable, but not required in administrative position.
Good communication skills · Experience with administrative work; high level of organization skills
English - advanced (spoken, written); Experience with MS Office Word, Excel
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.
Our 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.
