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Summary

I am a very precise and meticulous worker, always available to perform tasks assigned to me. Thanks my determination, I have always been involved in very ambitious working projects that help me to develop always a positive approach to the job such as to see every problem as a new opportunity. I love challenges and I see in the continuous improvement the key for the professional and personal growth.

Experiences

Current Experience

  • Jr Regulatory Affairs
    Since April 2016
    • Execution of Variations of products in MRP and National procedures. • Review/approval of packaging material both Italian ones and German ones for Bilingualism

Past Experience

  • Pharmacovigilance
    June 2015 --- December 2015
    Main activities to support the Sr. Safety Manager both for Investigational and marketed products: • Timely and accurate intake of ICSRs reported through the Italian Pharmacovigilance Network (or any other source) and subsequent translation and data entry activities. • Excellent knowledge and continuous use of MedDRA dictionary and ARGUS database • Management of follow-up and queries of individual cases through the ARGUS database. • Management and distribution of periodic safety reports such PSUR, DSUR,QSUR to the Regulatory Authority AIFA and/or Ethic Committees as required by local regulations and Amgen procedures. Management of SAE and SUSARs. Distribution of DHL and DIL • Archive and update all the documentation referring to the CE approval; opening and closure of clinical trial centers. • Facilitate exchange of adverse event information with functional service providers and business partners in line with specific agreements and procedures. • Knowledge of Summary of Products Characteristics, Investigator Brochures and Risk Management Plans to support the activities related to the safety of Amgen products • Acquisition of risk minimization materials (such as patient alert cards, educational brochures for physicians, nurses and patients) and subsequent translation and sending to AIFA • Ensure that local safety activities are documented and filed or archived in line with Amgen/GRAAS policies and procedures • Awareness of the procedural aspects related to the Screening of Medical Literature performed by the European Medicines Agency (EMA) • Awareness of the aspects related to the safety reporting in the clinical trials as required by Regulation EU No 536/2014. Trainings on the Regulatory Affairs: - Negotiation with AIFA for the pricing and reimbursement - Approvals of scientific information materials - Variations of the patient information leaflets - Organization of conferences and congresses - Regulatory aspects related to the clinical trials

  • Medical Sales Representative
    January 2012 --- May 2015
    Scientific information activities dedicated to the physicians (both general practitioners and specialists) performed through innovative methods of communication [Tele-Conference, Video-Conference, Web-Interaction] in favour of some of the major pharmaceutical companies: AstraZeneca, Dompè, Johnson&Johnson, Zambon, Galderma, LeoPharma and Amgen. This activity was aimed at increase medical prescriptions and was supported by the intense scientific training, professionalism and strong empathy towards the healthcare professionals. Corporate training: • Communication training aimed to optimizing the medical interview and pharmaceutical marketing strategies training • Pharmacovigilance training • Professional English training

  • Customer Service Specialist
    March 2007 --- March 2009

Personality

Self Assessment :
AdaptabilityApproachabilityAssertivenessAttention to detailCollaborationCommunicativeCoordinationCreative thinkingDependabilityDiligenceEfficiencyFlexibilityInterest in knowledgeProactivityProblem solvingReaction to stressResiliencyResponsibilityResult OrientedSelf-disciplineService orientedStrategic thinkingStrivingTrustWillingness to compromiseSociability

Knowledge

Self Assessment :
Biochemistry BiostatisticsNegotiation R&D Phase IAdverse Events (AE)Allergy and immunologyAnalytical ChemistryAnalytical methodsBioanalysisCAPACancer Research BiochemistryGood Clinical Practice (GCP)InflammationICH guidelines
LinkedIn Assessment :
Industria FarmacéuticaMicrosoft OfficeMicrosoft ExcelMicrosoft WordPowerPointPharmaceutical IndustryPharmaceutical salesPharmacovigilanceMarketing CommunicationsMarketing StrategyStrategic PlanningProject ManagementRegulatory affairsStrategia di marketingVendite farmaceuticheFarmacovigilanzamanagementBiotecnologíaAnalisi di mercatoAssistenza sanitariaMarket AnalysisPianificazione strategicaProject ManagementSperimentazioni clinicheLavoro di squadraMarketing

Skills and Expertise

Self Assessment :
Control data Develop clinical trial protocols Interpret data Monitor a clinical study Receptor Pharmacology Write protocolsAdvise on medical perspectivesBuild trial master file (TMF)Clinical data collectionCollaborate with medical teamConduct literature searches. Analytical skills Build and manage the Trial Master File (TMF)Create SOPsAct as the main line of communication between the sponsor and the investigatorAdverse event reportingWrite final reportsWork with coordination and data management teamsWork cross-functionallyWork collaboratively with the other members of the clinical research team

Education

  • in University Master's Degree in "Pharmacovigilance, Regulatory Affairs and Pharmacoepidemiology" from Seconda Università degli Studi di Napoli, Naples (Italy) in 2015
  • Pharmacy degree in from Università degli Studi di Napoli 'Federico II' in 2012
  • in from Farmacia Morrica in 2010

Training and Certification

  • Master in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Italian
Native

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Clinical Research Associate (CRA) Medical Science Liaison (MSL)
  • Locations I am interested in:
  • Work From Home:
    No
  • International:
    Yes

Area / Region

Italy

Others

Driving License
  • No