Christelle Boczek

Experience

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  Laboratoires URGO

  Jul 2000 - Aug 2000

  Quality Assurance: Quality control – Medical Devices (Interim Mission)
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  Sanofi

  Jun 2001 - Jun 2001

  Quality Assurance: Quality Control of dry forms (Interim Mission)

  •Collaborating with teams in order to QA of dry forms; notions of GMP

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  CHU de Dijon

  Nov 2005 - Oct 2006

  Pharmacist in charge of Pharmacovigilance – CRPV (Regional Center of Pharmacovigilance)

  •Collaborating with Clinical teams for adverse events collect; data collect. Safety monitoring and AE/SAE reporting•Evaluating the clinical implications of safety data from pre-clinical studies, clinical studies, litterature and other information sources to establish the safety profile of drugs and manage the risk to patients.

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  APHM (Assistance Publique - Hopitaux de Marseille)

  Nov 2006 - Feb 2011

  Pharmacist In charge of Drug and Medical Devices -Residency : Hospital Environment Knowledge

  •Communication : Writing posters (>15), publication and oral communications in International and National Congresses. • Research in Health System: Clinical Pharmacology & Therapeutic Evaluation Unit (UMR CNRS 6193, CEIP). Addictovigilance, Timone , Marseille, FranceExcellent knowledges of hospital environment:• Pharmaceutical Analysis- Dispensation HIV Drugs at CISIH Sainte Marguerite Hospital, Marseille, France • Regional Management of Health System insurance, Marseille, France • Management of Medical Devices, La Conception Hospital , Marseille, France • Pharmaceutical Analysis- Dispensation, Caremeau Hospital , Nimes, France • Pharmaceutical Analysis- Dispensation- Management of ATU (Autorisation Temporaire d Utilisation); La Conception Hospital , Marseille, France • Regional Pharmacovigilance PACA Corse Center, Marseille, France Show less

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  Centre Hospitalier Universitaire de Nice (CHU de Nice)

  Mar 2011 - Jul 2022

  Clinical trials Manager & Clinical Quality Assurance Manager. PharmD

  70% clinical trials :•Management and coordination of National & International Clinical Trials (CT): Phase II-IV ; including more than 80% clinical trials with various industrial sponsors - 20% academic. •Development of number of clinical trials : growth by 500%From 25 studies 2014 to over 125 in 2021 - •Therapeutics areas: cardiology, neurology (multiple sclerosis; oncology), pneumology (Pulmonary Fibrosis), endocrinology (Diabetes), urology, neurosciences (memory/Alzeihmer desease) with Memory Resource Centre and Research Nice, pain Center (Cluster Headache; Migraine), ophtalmology, emergency; •Communication : Internal interactions with medical departments ( investigators doctors, nursing teams) and financial department (Clinical Research Direction (CRD)) and external departments with experts, CRO, CRA establishment or promoters industries, ambulatory patients•Implementation of CT:- Participation: from feasibility visits to closure visit.- Writing specific prescription and dispensation protocol and SOP (Standard Operating Procedures)- Calculation of additional costs and transmission of pharmaceutical incremental (CRD) to establish the Convention.•Asset tracking tests: - Receptions, supplies and storage treatments, dispensation, Randomization if necessary, Management of UTs , ensuring compliance•Fences and archiving CT:- Calculation of the balance sheet at the end of the additional costs and the transmission CDR•Development of Quality Assurance System in Clinical trials:- Updating and development of Quality Assurance system (SOP)- Audits- Knowledge of GCP (GPC -ICH)- Traceability : keeping data Records - Monitoring of indicators of activity and achievement of the annual activity report ; CAPA 30% Pharmacy :•Responsible for Updating National Regulations for pharmacy unit (prices, reimbursement; relevant laws,local decrees); validation of prescriptions (referent: Neurology-MS; Cardiology); Temporary Authorization of Use, Show less

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  Centre Cardio-Thoracique de Monaco

  Jun 2022 - now

  Hospital Pharmacist