Job Description
In this dynamic and fast growing environment we are looking for a high caliber Pharmacovigilance Officer who will be responsible for performing pharmacovigilance activities across a diverse portfolio of medicinal products.
Main duties and responsibilities:
- Handle internal reporting of PV data as per regulatory timelines.
- Conduct database searches, screen and review global/local literature as required.
- Prepare the Periodic Safety Update Reports (PSUR).
- Review and update of Safety Data Exchange Agreements (SDEAs) and liaise as required with all stakeholders in Greece or worldwide.
- Monitor and document safety data to identify trends and potential safety issues/signals.
- Review, process and record in company’s database Individual Case Safety Reports (ICSR), originating from Competent Authorities.
- Update EudraVigilance extended Medicinal Product Dictionary (XEVMPD).
- .Perform PV training to em...
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