Pharmacovigilance Associate

**Location: Siena - Italy**

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**Department: Clinical**

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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