Clinical Research Scientist and pharmacovigilance professional looking to work in a promising and, developing company in the areas of clinical trials, pharmacovigilance /regulatory affairs or medical writing.
Several years of pharmaceutical international experience in drug development and adverse event reporting. Responsible for authoring study protocols and final study reports, coordinating, implementing, and reporting pilot and pivotal studies globally. Familiar with scientific vocabulary, EMA and FDA regulations and, competent author of sections of regulatory submissions.
Used to report directly to management in USA and across EU.
Determined, well organized and very focused, always being able to learn fast and deliver results on a timely manner. Worked and lived in multiple countries and developed several interpersonal skills across multidisciplinary teams and cultures. Fluent in written and spoken English, Spanish and Portuguese.
Research Scientist UK, Antewerp & Madrid
May 2012 --- March 2017
- Managed and directed operational aspects of in vivo effectiveness companion animal pilot studies and acted as backup contact for pivotal studies
- Provided European input and global project planning and implementation in efficacy clinical trials in both therapeutics and parasiticides
- Lead, managed, and directed the operational aspects of the EU study drug development plans
- Planed and implemented all activities associated with studies including authoring and/or reviewing protocol development and preparation of final study reports according to the relevant internal & regulatory standards including GCP.
- Prepared regulatory dossier in partnership with Regulatory Affairs and assisted with Regulatory Submissions
- Liaised externally with opinion key opinion leaders, clinical experts and other contacts
- Generated and delivered study site trainings
- Monitored laboratory pilot and pivotal studies and acted as back up project lead for clinical pivotal field trials
- Managed project timelines and budgets
- Identified and selected CROs and establish contract agreements, and maintained a positive business collaboration with external collaborators and KOL.
- Effectively communicate and collaborate with associates and scientists in chemistry, biology, technology acquisitions, regulatory, statistics, operations and product commercialization
- Worked closely with internal colleagues in regulatory, NPP, procurement, legal, QA, stats.
DEPUTY EUROPEAN QUALIFIED PERSON FOR PHARMACOVIGILANCE Basingstoke, United Kingdom
July 2009 --- April 2012
- Back up contact point for Competent Authorities on a 24-hour basis for audits and inspections
- Ensured conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements;
- Author of pharmacovigilance SOPs and internal business processes
- Ensured a full and prompt response to any request from national Competent Authorities (both EMA and FDA)
- Responsible for authoring and submission of Periodic Safety Update Reports (PSURs) and Periodic Drug Experience Reports (PDERS)
- Reviewer of Pharmacovigilance sections of clinical trial protocols and final reports for European projects
- Provided benefit-risk evaluation information to Competent Authorities
- Responsible for receiving, assessing, and investigating global adverse event reports
- Worked closely with development teams on the elaboration of pharmacovigilance sections of dossiers
- Reviewed and assessed all AEs from companion animal trials for European Submissions
- Acted as global PHV Contact for companion animal innovation teams and projects
Acted as global contact for clinical aspects of signal detection and trending
Veterinary Surgeon Newcastle upon Tyne, United Kingdom
May 2005 --- June 2009
- Responsible for 24hours daily internal medicine routine consultations, hospitalization, imaging diagnosis and surgical procedures.
- Assisted referral consultations of internal medicine, cardiology and ophthalmology.
- Provided emergency veterinary services during out -of -hours services, being in charge of nursing and reception personnel during this times.
OFFICIAL VETERINARY SURGEON UK
March 2004 --- April 2005
- Responsible for supervision, implementation and enforcement of Food Safety UK and EU legislation in food processing plants
- Responsible for writing Safety procedures, risk assessments and conducting safety audits internally
- Knowledgeable of European legislation regarding Animal Welfare, Animal Health, Food Hygiene and Animal By-Products and Specified Risk Material Controls.
- Responsible for the supervision of practices of team of meat inspectors
- Responsible for the surveillance and reporting of unsafe practices and accidents during food preparation to competent authorities ( FSA and Defra)
- Responsible for daily monitoring ,identifying and reporting of potential zoonosis and food born diseases in meat premises
- Participated in regular collection of samples for the FSA program on surveillance of veterinary drugs/residues and banned substances in meat
- Responsible for ensuring total compliance with Animal Welfare Standards during transport to slaughter an during slaughtering
AdaptabilityAssertivenessAttention to detailAuthenticityCollaborationCoordinationEfficiencyFlexibilityInterest in knowledgeKindnessOptimismOrganizationOrientationProactivityProblem solvingResiliencyResponsibilityResult OrientedSelf-disciplineService orientedSociabilityStrivingTrustWillingness to compromise
Animal models R&D Scientific writingAdverse Events (AE)Animal HealthAnimal trialClinical DevelopmentClinical monitoringClinical Study DesignClinical study reportsClinical trial designClinical trial managementClinical trialsCRFCRODeveloping Clinical Trial ProtocolsGood Clinical Practice (GCP)Good Clinical Practice Veterinary (GCPv)In VivoLaboratory study designMedical writingMicrosoft PowerpointMicrosoft ProjectMicrosoft WordMicrosoft OfficeMicrosoft ExcelMultilingualPharmaceutical IndustryPharmaceutical DevelopmentPharmacovigilanceRegulatory affairsRegulatory submissionsReport WritingResearchSafety reportingScientific WritingStudy protocolsTeamworkTeam BuildingUnderstanding of regulatory guidelinesVeterinary MedicineWriting Study Procedures and SOPs
Skills and Expertise
Build and manage the Trial Master File (TMF) Create SOPs Design case record forms Develop clinical trial protocols Monitor a clinical study Report data Search literature on clinical trials Write protocols Write papersAdverse event reportingApprove monitoring reportsApprove queriesAssess adverse reactionsAssist with site trainingAssist study siteAttend seminarsAttend investigator meetingAttend steering committeebudgeting of R&D activitiesBuild trial master file (TMF)Calculate timelines for conducting and completing the trialcollaborate in research projects at universitiesCollect dataCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Conduct animal studiesConduct close-out visitsConduct literature searchesConduct studiesControl protocol versionsCoordinate projectsCoordinationDesign efficiency studyDevelop protocolsEnsure good clinical practice (GCP)Identify investigatorsManage clinical trial files/documentsMonitor dataOral presentationOrganise meetingsPlan work to meet objectives and deadlinesPlanning clinical studiesProvide trainingR&DRegulatory documentationRegulatory submissionsReport deaths to regulatory authoritiesReview monitoring reportsSchedule trial visitsSchedule sponsor monitoring visitsSearch literature on clinical trialsSelect sitesSerious Adverse Event (SAE) ReconciliationSet up a clinical studySource animalsStudy-related documentsWrite documentsWrite final reportsWriting regulatory documents
Veterinary Medicine in Veterinary Sciences from Faculty Veterinary Medicine, Lisbon in 2003