**Job Information**: - Industry Consulting
- Job Type Tempo pieno
- Date Opened 23/03/2026
- City Roma
- Country Italy **About Us**:
We are experts in the Life Sciences industry & Technology. We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains. We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations. We are seeking a Drug Safety Manager to support the delivery of high‑quality pharmacovigilance (PV) services for Life Sciences clients, ensuring full compliance with global PV regulations, client requirements, and Arithmos quality standards. Working closely with Senior Drug Safety leadership, this role combines operational oversight, regulatory compliance, and scientific rigor within PV projects. **Key Responsibilities**: - Support workflow development and delivery of Pharmacovigilance services
- Perform and oversee PV operational activities, including ICSRs, SUSARs, and literature screening
- Manage safety reporting in EudraVigilance (EVWEB) and XEVMPD (where trained and certified)
- Ensure preparation of PSURs, DSURs, and RMPs according to regulatory timelines
- Prepare and maintain Pharmacovigilance Agreements / SDEAs




- Provide oversight and quality control of day‑to‑day PV activities
- Support signal detection activities in collaboration with PV physicians
- Contribute to SOP development and review client procedures
- Support audit and inspection readiness and follow‑up of CAPAs
- Track compliance metrics and quality indicators **Required Profile**: - University degree in a scientific discipline (e.g., Chemistry, Pharmacy, Biology, Biotechnology)
- 2-3 years of experience in PV operations, including case processing, literature screening, or PVA activities
- Background as a Drug Safety Officer or similar PV role
- Experience in medical device safety reporting is a plus
- Strong knowledge of PV regulations and compliance requirements
- Fluent English
- Strong organizational, analytical, and teamwork skills
- Proactive, flexible, and detail‑oriented approach **What We Offer**:
At Arithmos, you will contribute to ensuring patient safety through high‑impact pharmacovigilance projects, working in a collaborative and quality‑driven environment. We offer professional and international growth opportunities, flexible working models, competitive compensation, and continuous development.

📌 Drug Safety Manager (Roma)
🏢 Arithmos
📍 Roma