PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.

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) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Personal data protection
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• MedDRA and WHO coding
• Database Outputs and Reports (including data for monthly reporting to clients)
• Workflow & resource management

Support of PV processes related to the ICSR management within PrimeVigilance and also to clients

Performing activities in the scope of ICSR management unit within agreed extent and timeframe

Performing activities in the scope of Periodic Reporting:

• Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. Periodic Safety Update Reports or Re-examination application materials) with the responsibility for the quality and content of the document and compliance with internal and external standards

• Support in all pharmacovigilance operations associated with medical writing

• Continuous self-education in all aspects associated with medical writing

Life Sciences Graduate, pharmacy, nursing, or other healthcare related qualification

Demonstrated experience in Pharmacovigilance including ICSR and Periodic Reporting

Why Should You Apply?

• You want  be involved in a wide range of interesting projects and studies
• You'd like  your  achievements  and hard work to be recognized
• You want to work for a growing company where there are opportunities for advancement
• You'd like to work in a company that has a great reputation with its clients and employees.
• Making a difference to people's lives matters to you