PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.

We are looking for Pharmacovigilance Officer to join our new Japanese team

Providing support to other activities undertaken by the project team on behalf of the client and the company

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

Mentoring and training of new and more junior employees within the department

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

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

Demonstrated experience in Pharmacovigilance

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