Sara Banfi Email and Phone Number

- Complete management of all Pharmacovigilance activities related to medicinal products with a mutual recognition and decentralised authorization. - Processing, including medical assessment and distribution/submission.- Collaboration with the Regulatory Department for new projects/ registration/ renewals/ LE/ MAH transfer etc of IBSA products including ad hoc preparation of PV documents (e.g. AdCO, Module 2.5).- Revision and updating of SmPC, package leaflets and CCSI for products marketed by IBSA Group.- Management of Safety variation with IBSA CH and IBSA IT (requested by HA/PRAC/CmDH) and sharing the approved changes with Affiliates, Local PhV etc including updating of tracking log.- Activity of Signal management of benefit/risk ratio for all products of IBSA Group.- Preparation /review of RMP, ( including educational material, if applicable) and tracking update.- Preparation and revision of response documents to PSUR evaluation received from PRAC/ CmDH.- Preparation and/ or review of PSUR and PADER- PV training of new employees/ ISF- Preparation, together with QPPV and QA of CAPA plans in response to internal/ external audit.- Revision of Clinical Evaluation Plan (CEP- CER) and PMCF (plan and report) of Medical Device.- Preparation of Safety Assessment (PSUR) and TREND ANALYSIS of MD as required by legislation.- Revision of all documents regarding the Clinical Studies (protocol, safety plan AE monitoring etc).

Complete management of all Pharmacovigilance activities related to a medicinal product with a centralized authorization. Processing, including medical assessment and distribution/submission, of adverse event reports from all sources (interventional and not-interventional studies, literature and spontaneous; preparation and submission of: periodic safety reports (PSURs), Development Safety Update Report (DSUR), Risk Management Plans (RMP) together with Medical Department (responsible for clinical data provision), signal detection, weekly literature review.

Coordination of procedures regarding Ethical Committee and administrative clinical trials filing towards European Countries, Switzerland and U.S; support to Clinical Team and CRAs in the preparation, handling, distribution, filing, update, maintenance and archiving of clinical documentation and reports.Support to the preparation of study in-house and on-site audits. Organization of international Investigators’ and Monitors’ meetings. Participation to international meetings as spokesperson.

- Responsible for the collection of specific information and set up/update of a database with site procedures to request/obtain ethical and administrative authorization. - Filing of site ethical and administrative authorization for new protocol, as well as for protocol amendments; monitoring of requests until authorization is obtained.- Preparation and finalization of contracts with sites (institutions and investigators).- Shipment of study documents/material to sites (CRFs/manual/tests-tube/etc). - Negotiation, finalization and management of contracts with Italian and foreign consultants. - Update of the National database on clinical studies (Osservatorio Nazionale sulla Sperimentazione Clinica - OsSC).- Pharmacovigilance activities: adverse events / safety report distribution (spontaneous and clinical trial reports).- Handling of Annual Safety Reports submission activities (to EC, Investigators, Authorities); notification and tracking of adverse events.- Preparation of presentations for internal and external meetings, organization of conventions (investigator’s meeting, advisory boards, CROs and vendors meetings ect.) and business trips in Italy and abroad; preparation of requests for the authorization of courses and congresses, filing to the Competent Authorities, for participations to the congresses; drafting of expenses; management of archives.- Project administrator of CTMS (database for clinical studies).

Responsible for international and national clinical studies: drug supply management; drug and budget template preparation; data entry; preparation of presentations for internal and external meetings; organization of conventions and business trips; set up and management of Trial Master files, archive, and general administration activities. Use of SAP for the management of any business activities

Organization of business trips, drug supply management (drug shipment to study sites, drug requests to head office, and stock tracking), expense reports, archives and general administration, data entry.