Pharmacovigilance Officer
AI Summary
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 Agreem
About this role
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 employees and partners.
Requirements
- BSc Degree in Life Sciences, Biology, Pharmacy. MSc Degree in relevant field will be considered an asset.
- At least 1 year of pharmacovigilance experience in pharmaceutical industry or in a PV services provider organization.
- Fluent in Greek & English.
- Computer literacy.
- Excellent communication skills.
Benefits
The Company offers competitive remuneration, continuous learning development opportunities, and a friendly and challenging working environment.
