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General tasks within Pharmacovigilance
A-consult offers pharmacovigilance assistance to the medical industry, which can be chosen, as a full package or tailored according to individual requirements.
Some of the elements offered are listed below.
- Registration of medical company at EMEA
- Code and submit product data to EMEA's Product database
- Database solution
- Surveillance and monitoring of pharmacovigilance communication from the authorities to the company
- Coding of safety reports (ICSR's) (incl.MedDRA)
- Electronic submission of serious adverse event reports
- Literature survey
- Preparation of Periodic Safety Updates (PSUR)
- Maintenance of company data, MedDRA and pharmacovigilance procedures
- Evaluation / preparation of a pharmacovigilance system for your company
- Act as Qualified Person responsible for pharmacovigilance (QP PhV) on behalf of you company
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