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Experiences

Current Experience

  • Pharmacovigilance Assistant

    Rome, Metropolitan City of Rome, Italy
    Since December 2015

    - Quality Control of the daily check of the italian medicines agency (aifa) safety database (italian
    Pharmacovigilance network, rnf) and of the data reported in the registers
    - Quality Control of adr case reports loaded into the ccs safety database
    - recording of the adr case reports collected for the client companies (ccs) for which di renzo
    acts as local contact point (lcp) in specific registers/Databases
    - Translation of italian adr case reports into English by using a form agreed with eu
    qppv/Pharmacovigilance (pv) headquarters
    - sending to the eu qppv/pv headquarters of all italian adr case reports (initial and follow up), with
    the exception of cases detected through the literature search
    - performance of follow up activities (sending of the follow up requests, recording of the follow up
    attempts, receipt of the follow up information)
    - Data entry of the adr case reports into the ccs safety database
    - identification, Validation and confirmation of safety signals
    - implementing and maintaining the psmf and ensuring that the psmf is an accurate and up-to-date
    reflection of the mah's pv system
    - identification, Validation and confirmation of safety signals
    - review and approval of the psurs
    - review and approval of acos
    - providing input to the preparation of regulatory action in response to emerging safety concerns (e.g.
    variations, usr, Communication to patient and hcps)
    - providing input to preparation of sections of contractual agreements that relate to responsibilities for
    pv activities and safety data exchange (sdea)

    - Quality control of the daily check of the Italian Medicines Agency (AIFA) Safety database (Italian
    Pharmacovigilance Network, RNF) and of the data reported in the registers
    - Quality control of ADR case reports loaded into the CCs Safety Database
    - Recording of the ADR case reports collected for the Client Companies (CCs) for which Di Renzo
    acts as Local Contact Point (LCP) in specific registers/databases
    - Translation of Italian ADR case reports into English by using a form agreed with EU
    QPPV/Pharmacovigilance (PV) Headquarters
    - Sending to the EU QPPV/PV Headquarters of all Italian ADR case reports (initial and follow up), with
    the exception of cases detected through the literature search
    - Performance of follow up activities (sending of the follow up requests, recording of the follow up
    attempts, receipt of the follow up information)
    - Data entry of the ADR case reports into the CCs Safety Database
    - Identification, validation and confirmation of safety signals
    - Implementing and maintaining the PSMF and ensuring that the PSMF is an accurate and up-to-date
    reflection of the MAH's PV system
    - Identification, validation and confirmation of safety signals
    - Review and approval of the PSURs
    - Review and approval of ACOs
    - Providing input to the preparation of regulatory action in response to emerging safety concerns (e.g.
    variations, USR, communication to patient and HCPs)
    - Providing input to preparation of sections of contractual agreements that relate to responsibilities for
    PV activities and safety data Exchange (SDEA)

Past Experience

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAttention to detailCollaborationCommunicativeCreative thinkingCritical thinkingCuriosityDiligenceEfficiencyFlexibilityInterest in knowledgeOptimismOrganizationProblem solvingResponsibilitySelf-disciplineStrategic thinking

Knowledge

Self Assessment :
Biochemistry Cell biology Lab scale batches Labtechnician Phase I R&D Scientific writingAdverse Events (AE)Allergy and immunologyAnalysisAnalytical ChemistryAnalytical Method ValidationAnalytical methodsAnalytical proceduresAnalytical techniquesAnimal ModelsAnimal trialAntibodiesAssay developmentBiological Drug DevelopmentBiologyBiomarkersBiomedical SciencesBiopharmaceuticalsBiotechnologieBiotechnologyCancerCancer ResearchCAPACell Based AssaysCell biologyCell CultureCell SignalingCellular Product DevelopmentcGMPChemistryChemistry, Manufacturing, and Controls (CMC)ChromatographyClinical DevelopmentClinical monitoringClinical pharmacologyClinical researchClinical Study DesignClinical trialsCMC CMC Regulatory AffairsComputational BiologyConfocal MicroscopyCompliance with regulationsCROCross-functional team leadershipData AnalysisData entryDeveloping Clinical Trial ProtocolsDNADNA extractionDNA sequencingDrug AccountabilityDrug DeliveryDrug DevelopmentDrug development processDrug DiscoveryDrug InteractionDrug metabolismDrug regulatory authoritiesDrug Safety and PharmacovigilanceDrug safety assessmentDrug substancesElectrophoresisElectrophysiologyELISAEMAEndocrinology and metabolismEnglishEnzyme AssaysEnzyme-linked immunosorbent assay (ELISA)ExperimentationFACSFluorescence MicroscopyFlow Cytometrygas chromatographyGel ElectrophoresisGene therapyGeneral MedicineGeneticsGenetic polymorphismGenomicsGMPGood Clinical Practice (GCP)Good Laboratory Practice (GLP)Good Publication Practice (GPP)Good Manufacturing Practice (GMP)Grant Writinggrant writing and designHPLCHTMLPharmaceutical IndustryAutoclaveBacteriologyBioanalysisBioavailabilityBiochemistryBiomedical EngineeringClinical study reportsDrug substance developmentGraphPad PrismHardware DiagnosticsImmunocytochemistry (ICC)ImmunoassaysImmunofluorescenceImmunohistochemistryICH guidelinesImmunohistochemistry (IHC)ImmunoprecipitationImmunologyIn VitroIn vitro diagnostics (IVD)In VivoInfectious diseasesInflammationInformaticsISOISO 13485ISO 14001ISO 14971ISO 17025ISO 9000ISO 22000AutoCADCurrent Good Manufacturing Practice (CGMP)DatabasesJavaLaboratoryLaboratory Animal MedicineLaboratory ManagementLaboratory ResearchLaboratory SkillsLaboratory study designLaboratory TechniquesLaboratory testingLabtechnicianLarge MoleculesLaTeXLC-MSLife SciencesLifesciencesLinuxLiquid Chromatography-UV (LC-UV)Liquid chromatographyMammalian Cell CultureManufacturingMarket researchMarketing Authorisation Application (MAA)MatlabMATLAB (matrix laboratory)Microbiological TechniquesMicrobiologyMicroscopyMicrosoft OfficeMicrosoft ExcelMicrosoft PowerpointMicrosoft WordMolecular & Cellular Biologymolecular biologyMolecular CloningMolecular DiagnosticsMolecular geneticsMonitoring Study ProgressMolecular ModelingNanomedicineNanotechnologyNegotiationNeuroscienceNeurosurgeryOncologoncologyOncology Clinical ResearchOrganic ChemistryOutlookOxidative stressPathologyPathology labsPatient Follow UpPCRPeptidesPharmaceutical DevelopmentPharmaceutical managementPersonalized MedicinePharmaceutical ResearchPharmaceutical SciencesPharmaceuticalsPharmacistsPharmaceuticsPharmacodynamicsPharmacogeneticsPharmacogenomics (study of genetic variation)pharmacologyPharmacovigilancePharmacyPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PhotoshopPhenotype PharmacokineticsPolymer ChemistryPotency assaysPowerPointPre-clinical researchPreclinical developmentPreclinical regulations and practicesPosition PaperPreclinical SafetyPreclinical ResearchProblem SolvingProblem-solving methods and troubleshootingProduct developmentProgrammable Logic Controller (PLC)Protein chemistryProtein Engineering Animal modelsAuditingInstrument Validation ProtocolsISO 9001Mass SpectrometryMetabolismNMRProtein ExpressionProtein PurificationProteinsProteomicsProtocolPrototyping techniquesPurificationQA complianceQC releaseqPCRQualificationQualitative ResearchQuality Assurance (QA)Quality AuditingQuality Control (QC)Quantitative PCR (qPCR)real-time PCRrecombinant DNA technologyRegulatory affairsResearchRNA isolationRT-PCRSafety concerns (such as therapeutic ratio with respect to possible adverse effects)scienceScientific WritingSDS-PAGESearch literature on clinical trialsSequence AnalysisSequencingSerious Adverse Event (SAE)Small moleculesSpectroscopyStandard Operating Procedure (SOP)Stem cell researchStem CellsSterile drug productsSterilizationTechnology DevelopmentTestingTissue CultureTrainingTransfectionTranslationTranslational MedicineTranslational ResearchTroubleshootingUnderstand how results translate to practiceUnderstand levels of research evidenceUnderstanding of regulatory guidelinesValidationWestern BlottingWriting Study Procedures and SOPsWomens HealthActions and modes of action of drugs in the human speciesActions and modes of action of human physiologyCell EncapsulationCharacterizationCleaning ValidationDesign of Experiments (DOE) Designing case report formsEnglishHealthcare industryHospitalsReport WritingScientific CommunicationsScientific methodologyScreen patientsStudy protocolsVaccines

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Control data Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Guide students Interact with physicians Interpret data Lab scale batches Molecular Diagnostics Monitor a clinical study Report data Search literature on clinical trials Use a confocal microscopy Receptor Pharmacology Technology research Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdverse event reportingAnalyze data/information to determine potential relationships.Analyze proteinAssess quality process issuesAssign activitiesAssist study siteAssist with experimentsAssist with proceduresAssist with routine testsAssist with site trainingAssure medical qualityAttend seminarsAttend seminars, courses and meetings within and outside the companyAttend investigator meetingBiomarker ResearchCell cultureClinical data collectioncollaborate in research projects at universitiesCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collect dataConduct literature searchesConduct literature searches.Conduct studiesConduct supply issue resolution activitiesConduct the trialConduct university research Confirm protocol complianceContact potential subjectsCollaborate with principal investigatorConduct research at universitiesControl protocol versionscoordinating research projectsCoordinationCreate clinical documentsCreate SOPsCreate standard operating procedure (SOP)Data entryData validationData verificationDesign protocolDesign protocolsDesign scientific experimentsDesign scientific projects (in biology)Design studyDevelop extraction methodsDevelop ICH/GCP compliant processesDevelop protocolsDocument data reporting systemsDocument data collection systemEvaluate physico-chemical dataEvaluate physico-chemical data of lab scale/pilot scale batchesEvaluate protocolsEvaluate stability data Evaluate stability data and impurity identification/synthesisExecute scientific projectsExtrapolate dataInteract with pharmacistsInteract with physiciansInteract with nursesInteract with pre-clinical scientistsInterpret analytical resultsInterpret dataInterpret research resultsInterpret scientific datalifescienceManage complexityManage data collection systemManage data reporting systemsManage contractors Manage global quality standardsManage laboratory proceduresManage multiple projectsManage projects resourcesManage publication strategy of clinical trial resultsmanaging a small teamManuscript preparationManuscript preparation and reviewManuscript reviewControl studiesCoordinate projectsDesign clinical presentationDesign case record form (CRF)Design data collection systemsDesign data reporting systemsDesign database Develop clinical hypothesesDevelop business planDevelop regulatory strategyEnsure good clinical practice (GCP)Interact with statisticiansInterpret electrical schematicsManage regulatory activitiesManage research projectsManage study supplyManage study budgetObtain grantsOral presentationOrganise meetingsOrganize scientific projects (in biology)Oversee data collectionOversee the process of cell line generationpcrPre-study procedures Prepare final reportPrepare manuscriptPrepare regulatory documentsPresent clinical resultsPresent data at congressProvide technical supportProvide trainingPublication of articlesPublish scientific projectsQuality control processR&DRead medical literatureRead medical literature to maintain current awareness and knowledgeRegulatory documentationRegulatory submissionsReport serious adverse events (SAE)Research at universitiesResolves queriesReview dataReview clinical study reportsReview data interpretationReview experimental plansReview protocolsReview quality control activitiesReview reportsReview queriesReview study protocolsReview the interpretation of dataSearch literature on clinical trialsSerious Adverse Event (SAE) ReconciliationSet up research projectsSetup of research equipmentSupervise analysts and researchersSubmit regulatory applicationsSupervise data processingTeach university studentsUnderstand protocolsUse fluorescence microscopyUse laboratory techniquesUse western blotting techniqueValidate dataVerify dataWork collaboratively with the other members of the clinical research team Work cross-functionallyWrite documentsWrite final reportsWrite papersWriting regulatory documentsWritten presentation

Education

  • Ph.D. in Biochemistry and Molecular Biology from University of Calabria in 2015
  • Master in Chemistry & Biology from University of Calabria in 2012

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Italian
Native
French
Elementary Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Publications

    Expert has 6 publications (Will be avalible with full profile)

Area / Region

Italy

Others

Driving License
  • No

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