Global Safety Specialist

About the role

Dompé, a biopharmaceutical company focused on innovative therapies, is seeking a Global Safety Specialist for its Tirana office. You will be responsible for managing pharmacovigilance activities throughout the product lifecycle, ensuring compliance with European and international safety regulations.

Key responsibilities

• Collect, classify, control and store Individual Case Safety Reports (ICSRs) from all sources.
• Access EudraVigilance to download, intake and report ICSR data accordingli​ to assigned roles.
• Assess reportability of ICSR cases and manage follow‑up requests.
• Process ICSR cases in the safety database and prepare individual reports (ICSRs and SUSARs) for regulatory submission.
• Submit ICSR data to regulatory authorities and partners within required timelines.
• Monitor, track and document national and international scientific literature.
• Provide backup support to Dompé GPS2 and assist during global audits or inspections.
• Collect and manage adverse event reports for other company products (medical devices, food supplements, cosmetics).
• Assess product quality complaints from a pharmacovigilance perspective.

Required profile

• University degree in Life Sciences.
• Fluent written and spoken English and Italian.
• Knowledge of applicable pharmacovigilance regulations and European law requirements.
• Certification as an EudraVigilance user.

Required skills

• Proficiency with MS Office (Excel, PowerPoint).
• Experience using MedDRA terminology tools.
• Ability to work with a pharmacovigilance safety database.