Responsible of Pharmacovigilance UnitSuccesful PV Audit ResultsPreparation and Implementation of Risk Management PlansInterface with Key Company Areas (Marketing/Training/Legal/Regulatory/Medical Managers/Medical information/Headquarters/Access/Clinical Research)100% of Compliance of regulatory and internal requirementsIn and out-licensing contracts elaboration and implementation100% of compliance in aggregate reports (PSURs, Safety reports for renewal, safety reports of… Show more Responsible of Pharmacovigilance UnitSuccesful PV Audit ResultsPreparation and Implementation of Risk Management PlansInterface with Key Company Areas (Marketing/Training/Legal/Regulatory/Medical Managers/Medical information/Headquarters/Access/Clinical Research)100% of Compliance of regulatory and internal requirementsIn and out-licensing contracts elaboration and implementation100% of compliance in aggregate reports (PSURs, Safety reports for renewal, safety reports of clinical trials)Experience of elaboration and implementation in post marketing early programs/Intensive and active Pharmacovigilance trials Show less

Comité científico

Coordinate all pharmacovigilance activities related with internal SOP and Local regulationTraining of PV items to Bioequivalence study sites and Phase IV and III clinical trialsPerforming of Pharmacovigilance studies, handling of documentation for opening, developing and close-out of sites.Run regulatory reports about local legislation using internal and external libraries (IDRAC, IMS, COFEPRIS, etc)Development of material training in Drug Safety topics and training to all… Show more Coordinate all pharmacovigilance activities related with internal SOP and Local regulationTraining of PV items to Bioequivalence study sites and Phase IV and III clinical trialsPerforming of Pharmacovigilance studies, handling of documentation for opening, developing and close-out of sites.Run regulatory reports about local legislation using internal and external libraries (IDRAC, IMS, COFEPRIS, etc)Development of material training in Drug Safety topics and training to all associates according timelinesSearching of adverse events of Company product in local and internal journals using global databasesUsing of several Safety and Quality environments databases for processing informationFull knowledgement of international regulations on Drug Safety and Regulatory affairsDrug Safety back-up for Chile and Ecuador subsidiariesResponsible of performing PSURs AND Risk Management PlansResponsible of performing Causality assessment for Adverse Events of local products Show less

Processing and reviewing adverse event cases reports from spontaneous reports and clinical trials submitted to global headquarters and local authorities 100 % of compliance of global SOP´s and local regulationsPeriodic internal training of global SOP´s related to pharmacovigilance, clinical trials and CQA activitiesTraining and record of adverse reporting process to investigators and CRA´s in initial site visits and in site Training and record of… Show more Processing and reviewing adverse event cases reports from spontaneous reports and clinical trials submitted to global headquarters and local authorities 100 % of compliance of global SOP´s and local regulationsPeriodic internal training of global SOP´s related to pharmacovigilance, clinical trials and CQA activitiesTraining and record of adverse reporting process to investigators and CRA´s in initial site visits and in site Training and record of pharmacovigilance activities to internal associates and third parties Development of local procedures according to specific local needsPreparing and compliance of drug safety activities for global and regional inspections according CQA audits guide and CQA audit procedures (checklist)Development of pharmacovigilance national audit guide for the pharmaceutical industry together other companies and national health authority. Show less

Coordinating and editing answers of requests coming from marketed and late development compounds by gathering information from multiple sources (internal documents, published materials, etc)Management of several Internal and external medical information databases (Embase, Pubmed, OVID, Science direct, ISI web of knolewdge, Biosys, IDRAC, etc) and training of users from multiple areas.Coordinate and run diverse literature searches for brand teamsManage medical inquires by… Show more Coordinating and editing answers of requests coming from marketed and late development compounds by gathering information from multiple sources (internal documents, published materials, etc)Management of several Internal and external medical information databases (Embase, Pubmed, OVID, Science direct, ISI web of knolewdge, Biosys, IDRAC, etc) and training of users from multiple areas.Coordinate and run diverse literature searches for brand teamsManage medical inquires by responding directly or by escalating the requests to the appropriate local or global contact Screening of adverse events in local literature for more than 150 drugs using several databases as Medigraphic, Imbiomed, Redalyc, Artemisa, Scielo, Embase, Medline Show less

Monitoring of several protocols Phase III and IV clinical trialsCompliance of 100% related to protocols activities (checking of informed consents, medical chart, CRF´s, drug storage, sending of information to sponsor, handling of laboratory results, closed interaction with investigators, fast approval of protocols by health authorities, full compliance of good clinical practices, international and local laws, etc)Appropriated preparation and compliance of clinical trials… Show more Monitoring of several protocols Phase III and IV clinical trialsCompliance of 100% related to protocols activities (checking of informed consents, medical chart, CRF´s, drug storage, sending of information to sponsor, handling of laboratory results, closed interaction with investigators, fast approval of protocols by health authorities, full compliance of good clinical practices, international and local laws, etc)Appropriated preparation and compliance of clinical trials activities for global and regional inspections according internal audits guide and CQA audit procedures (checklist)100 % of compliance of global SOP´s and local regulations related to clinical trialsTraining and record of adverse reporting process to investigator’s team in initial site visits and periodically Show less