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Job Description
- Responsible for maintaining of the pharmacovigilance system
- Single point of contact between the authority and MAH
- Searching and screening the literature to be accessible for all information regarding the molecules
- Preparation of all files of pharmacovigilance as Periodic safety reports (PSURs), risk management plans (RMPs), post authorization safety studies (PASS).
- Collections of individual case safety reports (ICSRs), assessment, management of the data, follow up.
- Reporting of the adverse events to EPVC according to stated time frames
Job Requirements
- Years of Experience 1+
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