The role is aimed to support the QPPV/ Global Pharmacovigilance Director in promoting, maintaining and improving the compliance with legal requirements applicable to the Angelini Italian companies. Ensure the management of the specific assigned PV tasks in compliance with the global and local SOPs.Main tasks:>Represent the local reference contact point for PV towards the national competent authority(AIFA);>Support at local level the QPPV in the fulfilment of GVPs, legal requirements and themanagement of the Angelini PV System;>Manage the PV topics for medicinal products and medical device products where the AngeliniItalian company is MAH/distributor and Manufacturer, respectively, in accordance with theAngelini global and local SOPs;>Ensure the preparation and submission to the Competent Authorities of aggregated safetyreports for the Italian medicinal/medical device products and Angelini products under clinicalinvestigations;>Coordinate the international literature monitoring activities for medicinal products included inthe PSMF and at local level for the Italian medicinal products;>Ensure the adequacy and performance of external service providers supporting ItalyPharmacovigilance in PV topics;>Ensure the review before finalization the safety sections of study protocol, operational manualand final study report of sponsored clinical trials;>Ensure the correct SAE management occurring in sponsored clinical trials;>Ensure the national Competent Authority websites monitoring to capture any new.

The main activities were related to the preparation of safety reports, reviewing the safety sections of the documentation of sponsored clinical trials, management of safety aspects on market surveys, patients support programme and websites/social media monitoring.

Support activities at Drug Safety Department:>Preparation, processing, review and finalization of Periodic Safety Update Report (PSURs), Risk Management Plans (RMPs) and Development Safety Update Report (DSUR);>Revision, quality control and archiving of processed individual case safety reports (ICSRs)

>Preparation, processing, quality control, review of periodic safety update report (PSURs) and risk managment plans (RMPs) within the EU towards Competent Authorities (CAs) and License Partners and/or Local Contact Points (LCPs);>Coding and pre-medical assessment of Individual Case Safety Reports (ICSRs) downloaded from the Pharmacovigilance Network "RNF";>Check of AIFA RNF on daily basis and dedicated mailbox;>Scientific literature: worldwide and local identification of case reports/clinical study published on scientific journals for active substance.

> Managing Health Care's non-electronical and electronical medical prescriptions;>Assuring correct dispensing of human medicines to the local population, giving advices on OTC-SOPs and homeopathic remedies.

> Ensuring regulatory compliance of parallel import of human medicines;>Interacting with the suppliers on a regular basis, providing technical consultancy and punctual updates regarding economical feasibility and margin of the interested products;>Managing and directing secondary repackaging at the productive site.

>Monitoring and saving safety data from the National Pharmacovigilance Web;>Scientific and Regulatory assessment on safety documentation sent by Pharmaceutical companies.

> Conducting experimental activities with animals on social behaviour;> Writing, studying and researching scientific articles based on non-clinical experimentations.