
Compliance Specialist
2 days ago
In this fast-paced and dynamic work environment, we are seeking a skilled Pharmacovigilance Officer to join our team.
Key Responsibilities:
- Report PV data internally according to regulatory timelines
- Conduct database searches, screen, and review global/local literature as required
- Prepare Periodic Safety Update Reports (PSUR)
- Review and update Safety Data Exchange Agreements (SDEAs) and liaise with stakeholders in Greece or worldwide
- Monitor and document safety data to identify trends and potential safety issues/signals
- Review, process, and record Individual Case Safety Reports (ICSR) originating from Competent Authorities
- Update EudraVigilance Medicinal Product Dictionary
- Provide pharmacovigilance training to employees and partners
Requirements
- Bachelor's Degree in Life Sciences, Biology, Pharmacy. Master's Degree in relevant field considered an asset
- At least 1 year of pharmacovigilance experience in pharmaceutical industry or PV services provider organization
- Fluent in Greek & English
- Computer literacy
- Excellent communication skills
- Analytical and critical thinking, problem-solving ability
- Self-motivated & results-oriented with ability to cope with strict timelines
Benefits
The company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
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