Experience

CROss Alliance®

• Switzerland
• Research Services
• 1 - 100 Employee

• Clinical Project Leader

  • Feb 2021 - Present

  CROSS Research SA - Mendrisio, Canton Ticino, Svizzera

• Clinical Research Associate and Clinical Trial Assistant

  • Jan 2019 - Jan 2021

  CROSS Research SA - Mendrisio, Canton Ticino, Svizzera

• Clinical Trial Assistant

  • Jul 2018 - Dec 2018

  CROSS Research SA - Mendrisio, Canton Ticino, Svizzera • Supporting the Clinical Project Unit in project management activities and in the management of study documents and files • Setting up, maintaining and finalising TMFs and ISFs • Autonomously obtaining study documents from inside and outside the company • Giving support for the preparation, control and submission of studies to the Regulatory Authorities (EC and CA) • Quality Controlling (QC) regulatory documents • Preparing eCTD compliant documents



Polichem SA - Almirall company

• Clinical Information Associate

  • Jan 2017 - Jun 2018

  Lugano Mission: Based on best international practices, capture, integrate and store clinical trials information (data and documents) to allow on-going data analysis and results reporting to access efficiently to clinical data of corporate medicinal products and to allow a shorter decision making process. Functions and responsibilities: ▪ Ensure Operational Data entry on time and data quality control over the IMPACT® system ▪ Ensure all Key Documents are properly stored into the… Show more Mission: Based on best international practices, capture, integrate and store clinical trials information (data and documents) to allow on-going data analysis and results reporting to access efficiently to clinical data of corporate medicinal products and to allow a shorter decision making process. Functions and responsibilities: ▪ Ensure Operational Data entry on time and data quality control over the IMPACT® system ▪ Ensure all Key Documents are properly stored into the Almirall Document Management Systems ▪ Provide instructions and follow up with CROs by means of the Study Information Plan agreement ▪ Oversee CROs Quality Control (QC) process on clinical trial documents to ensure accuracy, consistency, and completeness ▪ To provide planning, updating & reporting of clinical development projects/trials periodically ▪ Prepare and deliver Operational reports by means of the standard reporting tools ▪ Support the global compliance of the Clinical Trial Disclosure policy and Corporate SOPs ▪ Administration of Public registries databases such as: ClinitalTrials.gov, EudraCT & Almirall Corporate Web Site ▪ Collaborate in the selection processes of CROs ▪ Support on training activities of internal and external users in clinical systems and in processes for correct electronic information management. Show less



Polichem SA

• Deputy Qualified Person for Pharmacovigilance - Vice Pharmacovigilance Manager

  • Jan 2015 - Dec 2016

  Lugano ▪ Responsible for the weekly literature search for Pharmacovigilance purposes ▪ Responsible for the daily Medical Literature Monitoring (MLM) on Eudravigilance database ▪ ICRSs data entry in the Pharmacovigilance SafetyDrugs® database ▪ Daily support to the QPPV on Pharmacovigilance and Materiovigilance activities ▪ Cooperation with the Technical, Pre-clinical, Clinical, Regulatory Depts. (literature search, revision and formatting of company documents) ▪ Management and… Show more ▪ Responsible for the weekly literature search for Pharmacovigilance purposes ▪ Responsible for the daily Medical Literature Monitoring (MLM) on Eudravigilance database ▪ ICRSs data entry in the Pharmacovigilance SafetyDrugs® database ▪ Daily support to the QPPV on Pharmacovigilance and Materiovigilance activities ▪ Cooperation with the Technical, Pre-clinical, Clinical, Regulatory Depts. (literature search, revision and formatting of company documents) ▪ Management and archiving of documents in accordance with company procedures (archiving software) ▪ Management of remote paper archive (external archive) ▪ Management of in-company and out-company training

• Scientific Assistant

  • Oct 2011 - Dec 2014

  Lugano ▪ Responsible for the weekly literature search for Pharmacovigilance purposes ▪ ICRSs data entry in the Pharmacovigilance SafetyDrugs® database ▪ Daily support to the QPPV on Pharmacovigilance activities ▪ Management and archiving of documents in accordance with company procedures (archiving software) ▪ Management of remote paper archive (external archive) ▪ Standard secretarial support to the Technical, Pre-clinical, Clinical, Regulatory Depts. (literature search, revision and… Show more ▪ Responsible for the weekly literature search for Pharmacovigilance purposes ▪ ICRSs data entry in the Pharmacovigilance SafetyDrugs® database ▪ Daily support to the QPPV on Pharmacovigilance activities ▪ Management and archiving of documents in accordance with company procedures (archiving software) ▪ Management of remote paper archive (external archive) ▪ Standard secretarial support to the Technical, Pre-clinical, Clinical, Regulatory Depts. (literature search, revision and formatting of company documents) ▪ Management of translation activities through third parties ▪ Management of in-company and out-company training ▪ Management and planning of trips, in-company and out-company meetings and events

• Regulatory Affairs Assistant

  • Mar 2006 - Sep 2011

  Lugano ▪ Registration procedures at worldwide Drug Agencies (National procedures, MRP and DCP) ▪ Registration dossier preparation (CTD and e-CTD format) ▪ MA renewal procedures and relevant dossier update ▪ Cooperation with the Technical, Pre-clinical, Clinical, and Pharmacovigilance Depts. ▪ Contact with API and finished product manufacturers ▪ Management of translation and legalization procedures ▪ Meeting minutes preparation ▪ Management and archiving of documents in… Show more ▪ Registration procedures at worldwide Drug Agencies (National procedures, MRP and DCP) ▪ Registration dossier preparation (CTD and e-CTD format) ▪ MA renewal procedures and relevant dossier update ▪ Cooperation with the Technical, Pre-clinical, Clinical, and Pharmacovigilance Depts. ▪ Contact with API and finished product manufacturers ▪ Management of translation and legalization procedures ▪ Meeting minutes preparation ▪ Management and archiving of documents in accordance with in-company procedures



Laboratorio SAN PAOLO s.n.c.

• Analyst

  • Feb 2005 - Sep 2005

  Lomazzo (CO) - Italia Clinical analyses: CBC, protein electrophoresis, viral antigen and antibody detection, hormone levels. Urinalysis and stool analysis. Microbiological cultures.



Polichem SA

• Regulatory Affairs Assistant

  • Feb 2004 - Sep 2004

  Lugano Maternity leave replacement



Università degli Studi di Milano

• Higher Education
• 700 & Above Employee

• Internship Student

  • Jul 2002 - Jul 2003

  Milano, Italia Molecular biology and cell culture techniques both for diagnostic and research purposes on HBV, HCV, HIV, HPV, HHV-8 and influenza virus.



Orologerie Gander di Paolo Gander

• Company Secretary

  • Jan 2000 - Jun 2002

  Como (I) Standard secretarial support, contacts with customers and providers, shipment activities.