SL

Silvia L.

GVP Compliance Expert & PV Auditor at PQE Group

Silvia L. has extensive experience in the field of pharmacovigilance and post-marketing vigilance. Silvia started their career in 2010 as a Student Researcher at Fondazione Telethon. Silvia then worked as a Student Researcher at CNR and Università degli Studi di Pavia.

In 2011, Silvia worked as an External Collaborator at the non-profit cooperative "Don Calabria", where they performed various roles including barmaid, waitress, salesgirl, and maintenance of the Botanical garden.

From 2012 to 2014, they worked as a Drug Safety Officer trainee at Boehringer Ingelheim. In 2015, they joined INTEXO as a Pharmacovigilance consultant, where they specialized in case management, literature screening, and editing SOP and WI.

Silvia then worked at PhAST Consulting S.r.l. as a Drug Safety Officer from 2016 to 2020, gaining expertise in drug safety operations.

Silvia joined Galderma in 2019 and held multiple roles, including Local Contact Person for pharmacovigilance and Local Responsible person for post-marketing vigilance for Medical Devices, Cosmetics, and food supplements.

In 2020, Silvia worked at SOL Group as a Pharmacovigilance Officer at the corporate level. Silvia later became the Corporate Pharmacovigilance Coordinator.

Currently, Silvia is working at PQE Group as a GVP Compliance Expert & PV Auditor. Silvia'sresponsibilities include supporting the creation and maintenance of pharmacovigilance and quality systems, PV QA support, PV audit conduction, and ICSRs management.

Throughout their career, Silvia has gained a deep understanding of pharmacovigilance regulations and processes, as well as experience in quality assurance, auditing, and training compliance management. Silvia is proficient in managing PV requirements for different types of medicinal products and has expertise in literature research and safety data analysis.

Silvia L. has an extensive education history. Silvia began their higher education at Liceo delle Scienze Umane "C.Montanari," where they obtained a Diploma di scuola superiore in 2008. Silvia'sstudies at this school focused on sociologia, psicologia, filosofia e pedagogia.

Following their time at Liceo delle Scienze Umane, Silvia pursued a Bachelor's degree at Università degli Studi di Ferrara. Silvia completed their Bachelor's degree in Biology, with a curriculum in Molecular Biology, from 2008 to 2011.

Continuing their academic journey, Silvia obtained a Master's degree in Molecular Biology and Genetics (in English language) from Università di Pavia. Silvia pursued their Master's degree from 2012 to 2014.

In 2015, Silvia enrolled in a second-level Professional Master's Program in Pharmacovigilance at Università degli Studi di Milano. Silvia completed this program in 2016, earning a Professional Master's degree in Pharmacovigilance.

Additionally, Silvia has obtained several certifications to enhance their professional skills. Silvia earned certifications in ISO 9001:2015, Data Integrity, Writing Effective Audit Findings, Introduction to The Audit Process, and Remote Audits and Inspections of Pharmacovigilance Systems from Research Quality Association (RQA) between 2021 and 2022. Furthermore, in 2012, they obtained the First Certificate in English (FCE - B2) from Cambridge School of English.

Based on this information, Silvia L. has been actively pursuing their education in various scientific fields, specializing in biology, molecular biology, genetics, and pharmacovigilance. Silvia has also demonstrated a commitment to professional development by obtaining certifications to enhance their expertise and skills in the research quality and audit processes.

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Timeline

  • GVP Compliance Expert & PV Auditor

    November, 2021 - present

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