Drug Safety Officer
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De opdrachtgever
Farmaceutisch bedrijf in Amsterdam.De omschrijving
The Drug Safety Officer is responsible for support on pharmacovigilance (drug safety) requirements performed on local level for all medicinal products and parapharmaceutical products. This includes local pharmacovigilance activities, the compliance with global and local procedures, archiving of all local pharmacovigilance documents and implement processes to improve the quality. The responsibility applies for all Marketing Authorizations, whether in the name of the respective local organization or another legal entity (e.g. central organization, license partner), which may have delegated such responsibility.- The Drug Safety Officer ensures processing of Individual Case Safety Reports.
- Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and parapharmaceuticals
- Record and review incoming ICSRs
- Translate ICSRs into English language and perform Quality checks
- Enter relevant data into local ICSR tracking tool and perform follow up activities
- Liaise with relevant stakeholders (e.g. QA, Medical, Service Providers) to ensure all relevant data are available
- Format and archive ICSR-relevant documents according to PV processes and policies
- Investigate any instances of non-compliance and manage PV investigation forms
- Contribute to Audit and Inspection preparations and the respective CAPAs
- Answering of medical questions (Medical Information).
De eisen
- Bachelor’s degree or equivalent degree with related health science or quality background
- Fluent in the Dutch and English language (can take an active role in business discussions and can perform relatively complex tasks)
- Excellent skills in using Microsoft Office applications including MS Excel and MS SharePoint
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