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Senior Pharmacovigilance Associate

Company

Ergomed

Location

Kraków, Lesser Poland Voivodeship

Type

Full-time

            Job Description 

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

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