Pharmacovigilance Officer
hace 1 semana
Company Description
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.
**Job Description**:
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
- More senior colleague may perform tasks assigned as per SOP to more junior position
- Performing activities in the scope of ICSR management unit within agreed extent and timeframe
**Qualifications**:
- Life Sciences Graduate, pharmacy, nursing, or other healthcare related qualification
- Demonstrated experience in Pharmacovigilance
- Ideally Argus database experience
- English, Advanced
Additional Information**
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
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