Andrea Pricca

Experience

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  University of Pavia

  Sept 2010 - Jul 2011

  Researcher

  Pharmaceutical Technology LaboratoryPreparation and characterization of injectable systems composed of thermosensitive composite hydrogel (ISFcG - In Situ Forming composite Gel) for bone regeneration.In collaboration with:- Fondazione IRCCS Policlinico San Matteo, Pavia (Italy)- Geistlich Pharma AG, Wolhusen (Switzerland)

• 

  Merck

  Jun 2012 - Dec 2012

  Process Specialist Intern- Global Technical Operations Department (GTO)

  Preparation and review of protocols, in accordance with cGMP, Merck Manufacturing Divisional Guidelines, Policies and Procedures Standard Site; sampling activities, data collection, management of atypicals/deviations, and compilation of Final Reports.Supervision of the manufacturing process for all the kind of products, including the newest one, built up following the brand new concept of Quality by Design (QbD).

• 

  TEOFARMA S.R.L.

  Apr 2013 - May 2014

  Management of worlwide Individual Case Safety Reports (ICSRs); Monthly reconciliations; Writing and/or reviewing standard operating procedures; Supervision of national and international PhV networks for new ICSRs; Management and request of Follow Up; Management of foreign consultants and Pharmacovigilance Local Contact Points. International and local literature screening. Participation to AIFA PhV Inspection and implementation of the consequent CAPA plan. Quality control of finished products and raw materials in laboratory, including High-performance liquid chromatography, Ultraviolet–visible spectroscopy, Infrared Spectroscopy and Thin-layer chromatography. Update of packaging, Patient Information Leaflet, SmPCs; Update of CTD/e-CTD and management of certificates (cGMP, CEP/COS, DMF, ISO, Hala/Kosher, Allergens, BSE/TSE, REACH, Residual solvents, GMO) for the products commercialized all over the world.

  • Pharmacovigilance Assistant

    Apr 2013 - May 2014

  • Drug Quality Control

    Jun 2013 - Mar 2014

  • Regulatory Affairs Officer

    Apr 2013 - May 2013
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  Dompé

  Jun 2014 - now

  Administrator of Company’s Global Safety Database (LifeSphere Safety MultiTenant Database - ARISg).Project Manager and Key User of Company’s Global Safety Database E2B R3 - Upgrade and Validation ongoing-Process.Reference Person for Management of Clinical Trials.Signal Detection Chairman of Clinical Trials.Member of Safety Review Board.Active participation to Inspections made by National Competent Authority (AIFA), European Competent Authority (EMA), American Competent Authority (FDA) and audit performed by third party provider and Partners.Preparation of Safety Aggregate Reports (PSUR/PBRER, DSUR, RMP, PADER, Clinical Overview) to Regulatory Authorities, Ethic Committees and Partners worldwide.Participation to Signal Detection process (extraction of data, participation to SRB meeting, review of SD report).Preparation, review and finalization of Policy, Governance (GOV), Standard Operating Procedure (SOP), Working Instruction (WI) and Pharmacovigilance System Master File (PSMF) at global level.Reference person for Biotech products: oversight of case processing and safety information exchange and submission at global level with Regulatory Authorities and Partners; management of relevant Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreement (PVA).Management of PhV for clinical trials (SAEs management, Reconciliation with Clinical Database, Protocol, IB and Safety Plan review).Reference person for clinical trials management at global level. Show less Administrator of Company’s Global Safety Database (LifeSphere Safety MultiTenant Database - ARISg).Project Manager and Key User of Company’s Global Safety Database E2B R3 Upgrade and Validation Process.Reference Person for Management of Clinical Trials.Signal Detection Chairman of Clinical Trials.Member of Safety Review Board.Collecting, classifying, triage, quality control, medical evaluation, follow up of International case reports from all sources, regarding medicinal products, medical devices, cosmetic products and nutraceutical products, for both investigational and marketed ones. Management of the PSMF.International and Local Literature screening supervisor. Management of PhV for clinical trials (SAEs management, Reconciliation with Clinical Database, Protocol, IB and Safety Plan review). Draft, finalization and management of Safety Data Exchange Agreements (SDEA). Participation to Signal Detection process (extraction of data, participation to SRB meeting, review of SD report).Generation, review and submission of Safety Reports (CIOMS I, line listings, tables, PBRERs, DSURs, RMP etc) to Regulatory Authorities, Ethic Committees and Partners. Support in writing and Quality Check of Safety Aggregate Reports (PSUR/PBRER, DSUR, RMP, Clinical Overview). Writing and review of internal SOP and WI.Supporting PhV training activity of internal/third party provider personnel. Monitoring compliance and performance (KQI and KPI) of internal and partners’ activities. Active participation to internal audit and CAPA resolution. Active participation to NCA (AIFA) PhV Inspection. Show less Collecting, classifying, triage, quality control, medical evaluation, follow up and archiving of all Italian and International adverse drug reactions (ADRs) from all sources for investigational and marketed products.Management of PhV for clinical trials (SAEs management, Reconciliation with Clinical Database).Generation, review and submission of Safety Reports (CIOMS I, line listings, tables, PBRERs, DSURs, RMP etc) to Regulatory Authorities, Ethic Committees and Partners.Support in the management of Safety Data Exchange Agreements (SDEA).International and Local Literature screeningSupport in writing and Quality Check of Safety Aggregate Reports (PSUR/PBRER, DSUR, RMP, Clinical Overview). Writing and review of internal SOP and WI.Supporting PhV training activity of internal/third party provider personnel. Monitoring compliance and performance (KQI and KPI) of internal and partners’ activities. Active participation to internal audit and CAPA resolution. Active participation to NCA (AIFA) PhV Inspection. Show less

  • Global Safety Ops Manager and Administrator Global Safety Database

    Mar 2022 - now

  • Global Safety Specialist and Administrator Global Safety Database

    Oct 2019 - Feb 2022

  • Safety Officer and Administrator Global Safety Database

    Jan 2016 - Sept 2019

  • Pharmacovigilance Consultant

    Jun 2014 - Dec 2015
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  United Therapeutics Corporation

  Nov 2016 - Dec 2017

  Local Contact Person for Pharmacovigilance

  24/7 availability with Italian Competent AuthorityManagement of RMP and implementation of RMMs at local level.Management of ICSR, collection, classification, triage, quality control, medical evaluation, follow up and archive of ICSRs from all sources for marketed product in the Italian Country.Reconciliation with local partners and US HQ on PhV activities