We are currently seeking a Drug Safety Manager for a CRO based in Italy with multiple offices in the UK and Italy, they are looking to add to their consulting unit with a new hire. They offer flexible working with training opportunities, conferences and more plus a generous salary and working benefits. **Responsibilities**: - Manage PV & Safety projects and/or staff allocated to those projects.
- Act as Project Manager for assigned projects/contracts and provide regular updates to the PV & Safety Director.
- Oversee project phases and deliver against milestones within budget and on time.
- Supervise and train junior staff, directly or through functional relationships.
- Participate in workflow development and strategic planning for PV Services.
- Develop and implement Safety & Project Plans and Safety Management Plans for Project/Client specific AE workflows and Services.
- Perform scientific literature screening.
- Update the PV archive with required documentation (either in paper or electronic).
- Register the Company on behalf of the Client in Eudravigilance when required by the project.
- Enter/report ICSRs and SUSARs to Eudravigilance via EVWEB (only if trained by a certified person or after completing the Eudravigilance course).
- Ensure preparation and submission of PSURs and DSURs according to relevant rules and agreed deadlines with the Client.




- Prepare and revise Safety Data Exchange Agreements/PV Agreements.
- Assist the PV physician in the Signal Detection/Management process.
- Assist in developing new standard operating procedures and work guidance and/or review Client SOPs, if applicable, for full compliance.
- Assist in ensuring audit/inspection readiness.
- Track compliance metrics.
- Assist in identifying and following up on corrective action plans arising from audits and inspections.
- Participate in training development programs for cross-functional personnel and external groups in drug safety principles and practices.
- Assist the PV Physician in developing Study Protocols, IBs, IMPDs, RMPs.
- May cover the role of QPPV and Deputy and Italian Local Contact Person for PV. Background & Experience: - University Degree in Scientific Subject
- At least 2-3 years (DSM) or 5 years (Senior DSM) of experience in PV Operations, including case processing, Pharmacovigilance Agreement writing, and literature screening.
- Proficient in English.
- Experience in GVP regulatory compliance
- Knowledge of Regulatory guidelines worldwide.
- Familiarity with Regulatory standards applicable to Pharmacovigilance. Contratto di lavoro: Tempo completo Retribuzione: €40.000,00 - €50.000,00 all'anno Orario: - Dal lunedì al venerdì
- No weekend Requisito linguistico flessibile: - Italiano non richiesto

📌 Drug Safety Manager (Roma)
🏢 Qualitas
📍 Roma