Junior Pharmacovigilance Associate

3 settimane fa

Siena, Italia Philogen A tempo pieno

**Location: Siena - Italy**
***
**Department: Clinical**
***
**Junior Pharmacovigilance Associate**
Philogen S.p.A. would like to hire a Junior Pharmacovigilance Associate. The role will report directly to the Responsible of Pharmacovigilance.
- Collaboration in the assessment, triage and management of SAEs and 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.
- Support in 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.
- Support in pharmacovigilance post-marketing activities.
- Scientific background
- 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

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