Location: Siena - Italy Department: Clinical Philogen S.p.A. is a biotechnology company whose mission is the development of biologic products for the imaging and therapy of life-threatening diseases, with a special focus on angiogenesis related disorders. Pharmacovigilance Associate Philogen S.p.A. would like to hire a Pharmacovigilance Associate. The role will report directly to the Responsible of Pharmacovigilance. - Collaboration in the assessment, triage and management of SAEs. - Collaboration in SUSAR submission (e.g.CIOMS-I form preparation). - Collaboration in the preparation and submission of the safety documents (e.g. DSUR and periodic safety reports) in accordance with applicable GCP requirements and legislation. - Preparation of the Communication and Notification to the Competent Authorities and Ethics Committees. - Assistant for the data coding using MedDRA dictionary. - Writing of Standard Operation Procedures (SOP) related to the Pharmacovigilance area. - Give support in preparation and in updating clinical documents including protocols, amendments, IB’s, interim and final safety reports to ensure regulatory compliance and safety throughout trial. - Maintenance and archiving of the paper Trial Master File in collaboration with the CTA. - Revision of clinical listings to clean safety data in collaboration with medical manager, CRA - and data manager. - Previous experience in Pharmacovigilance activities or a Master degree in Pharmacovigilance. - Excellent written, verbal and organizational skills. - Strong prioritization skills. - Ability to handle multiple projects and stressful situations. - Good skills in data analysis. - Excellent scientific writing skills and fluency of the English language. We offer: Job location: Siena - Italy