SENIOR PHARMACOVIGILANCE ASSOCIATE
Philogen S.p.A. would like to hire a Senior Pharmacovigilance Associate.
In particular the successful candidate will be responsible for:
- Collaboration in the assessment, triage and management of SAEs and SUSAR submission (e.g.CIOMS-I form preparation).
- Revision of clinical listings to clean safety data in collaboration with medical manager, CRA
- and data manager.
- Collaboration in the preparation and submission of the safety documents (e.g. DSUR and periodic safety reports) and in updating clinical documents including protocols, amendments, IB’s, interim and final safety reports to ensure regulatory compliance and safety throughout trial.
- Pharmacovigilance post-marketing activities, in particular preparation and maintenance of PSMF, RMP and Medical Literature screening.
- Preparation and validation local PV contracts.
- Writing of Standard Operation Procedures (SOP) related to the Pharmacovigilance area.
- Preparation of the Communication and Notification to the Competent Authorities and Ethics Committees.
The ideal candidate should have:
- Previous experience in Pharmacovigilance activities pre- and post-marketing (at least 2 years of experience in the role).
- Solid knowledge of local and EU PV regulations
- EudraVigilance training on electronic reporting of ICSRs in the ICH E2B(R3) certification
- Extended EudraVigilance medicinal product dictionary (XEVMPD) training certification
- Master’s degree in Pharmacovigilance will be consider a plus.
- 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.
A contract and salary proportional to the experience (seniority) of the successful candidate.
Siena – Italy