•Passionate, self-motivated, ethics with high integrity, quick learning, adaptive strategic leader, committed, fully trained physician.Board certified Gastroenterologist and Hepatologist. •Strong clinical background in many aspect of Internal Medicine (GI,IBD/Cancer/oncology adults &Paediatrics ((±13 Y) working at University Medical canters •Hands-on: in all aspect of Drug Safety Development (DS) activities (± 9 years) and in all Pharmacovigilance – Benefit/Risk management, signals(±6 Y) working in the Bio-Pharma industry. •Expertise in Authoring/review/approval of key aggregate reports (IB, protocols, Study Synopsis, Clinical Study Reports,NDA/ANDA, NDS, BLA, sCTD, MAA, monitoring plan for CT, SAE reporting plans), DSURs, SPC/SmPC/PILs, CSI/CCSI, PSURs, PBRERs, RMPs REMS/RME labelling activities, company responses to authorities queries, Company responses to Inspection findings, Gap analysis, CAPA plan preparation &execution, SOP writing. •Extensive knowledge and experience on International Laws, regulations ,PV legislation, FDA and in preparation/participation of Competent Authorities Inspections •Ability to build, create sustainable relationships with KOLs in different medical fields •Represent the company in complex relationships to target groups of patients, Authorities, Stakeholders, staff members at all levels. •Accountable for trainings on Medicinal Products (select/coaching) Medical/ Scientist teams •Demonstrated experience of balancing multiple tasks &in prioritizing to meet deadlines. Significant degree of Customer sensitivity/business acumen. Global cross-functional and cross-cultural team player. •Internal Medicine/GI& Hepatology/Dermatology/Immunology /Cardiology/Lipid related diseases/Diabetes/Nutrition/ Hematology/ •Oncology •Pediatrics •Infectious diseases: Hepatitis C/B virus, HIV & AIDS, Flu •Vaccines, Antiviral therapy, Immunoglobulins •Anticoagulants,Thrombolytics •Medical devices, Brand, Generics drugs •Biosimilars.
Pharmacovigilance Medical Expert
Since January 2014
-Update Hospira Pharcovigilance System Master File (PMSF) including different Annexes -MHRA Inspection preparation March 2014. -Providing PV training to EMEA. -Training on educational Materials for Inflectra. -PV internal audits providing support to Hospira affiliates -Review/ update of PV agreements including writing related processes --Preparation of Hospira response (April 2014) to FAGG - AFMPS - FAMHP Belgian Federal Authorities PV routine Inspection. -Involved in the Audit remediation Plan Croatia and Italy PV Authority Inspections -Authoring the remediation plan, preparation of ER, root causes- Investigation analysis, corrective and preventive actions, open and closure of CAPAS in TrackWise, effectiveness check, etc. -Setting up processes through creation of SOP, Work Instructions, templates, Forms, training's to different teams such as Quality Assurance, Medical Affairs (Medical Enquiries handling focus on ADRS, ICSR), Regulatory Affairs, Global Product Safety, Sales representatives, Local QPPVs and Local contact persons for PV. -Writing Risk Managemt Plan (new template) for Biosimilars - Regulatory review and approval of promotional and advertising materials for Hospira marketed products; taking into account local laws, royal decrees, Directive 2001/83/EC of the Community Code relating to medicinal products for human use, any external review requirements (Review by health authorities) and relevant Hospira internal policies and procedures. -Training and coaching on PV reporting obligations, new PV legislation-awareness, different GVP modules, product with Risk Management Plan, Product specific including Biosimilars. -Preparation of GVP modules Gap analysis -Authoring of responses to Competent Authorities inquiries -Drug quality Complaint Management and trainings -SmPC /CSI comparison- Clinical overviews module 2.5 -SPC (new QRD template) -Trackwise, EndNote, IRMS.
Deputy EAA QPPV Dublin
January 2013 --- December 2013
•In absence of the EU QPPV: Act as the single point of contact on a 24/7 basis, for all the Aspen affiliate companies, for the EMA and other competent authorities. - Contribute fully to ensure complete awareness of emerging safety concerns and safety profiles relating to all products for which the Aspen affiliate companies hold marketing authorizations. -Support QPPV in any Urgent Safety Restrictions and Safety Variations. Convene a Crisis Management Team meeting to discuss proposed USRs. - Successful implementation of the Signal Management Processes activities including signal detection activities, Signal Evaluation Report (SER) preparation, training, signal communications -Ensure that there is a Pharmacovigilance System Master File (PVSMF) & Summary in place and is up to date and available upon any Agency’s request. -Have an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the Aspen holds authorizations in EEA. -Setting up the process preparation of PSUR/PBRERs -Harmonization project of SPC/PILs WW. -Building and Leading the medical team -Performing the Medical review and approval of internationally developed marketing and promotional materials in order to guarantee compliance with medical ethics, new regulations and country lows (Quemotherapeutics drugs) -Preparation of Aspen response to Medical enquiries from Competent Authorities and including Health Care Authorities outside the EU.
January 2012 --- January 2012
•Part of the Global Risk management medical team of the BI global Safety evaluation CV and metabolism group. Accountable for risk management activities pertaining to assigned products, Signal detection, Authoring Signal Evaluation reports, improving template, signal communication.. · Training the CRO's medical teams on Product specific, case assessment, medical review, medical queries to complete narratives, creation of a compliance guideline for CRO's medical reviewers. · Participate in ongoing safety data review & analysis for the assigned products · Ensure all risk management documents are prepared according to regulatory requirements and facilitate review and sign-off · Assist in the management of Risk Management projects to meet timelines. Participate in other teams & committees as assigned . Part of the team accountable for the preparation/writing of sections of Pradaxa’s PBRER , Pradaxa’s Risk management Plan (RMP), including Risk Minimization Plans or REMS for submission to regulatory agencies •Part of the team responsible for the preparation of Actilyse’s PSUR (3 years and the monthly Cardiovascular Safety report
Medical Drug Safety Officer
December 2010 --- December 2011
•Author of around 30 safety documents (PSURs, Clinical expert statement, Bridging Reports, ASRs, DSURs)•Provides integrated safety input and review to key regulatory & clinical documents: i.e. IB, protocols, amendments, Clinical Study Reports, regulatory packages, SPC/SmPC/PIL, CDS/CCSI •Part of the team in order to create, processes, SOPs and templates •Strategic Clinical Safety Leader, responsible for continuous monitoring of AEs/SAE from clinical trials •Participation in MHRA Inspection July 2011 and Internal PV Audits Nov. 2011 •Part of the team providing safety input for the successful launch of Derma products in 2011 •Successfully consolidation of PSUR scheduling, production and outsourcing to enable efficiencies and achieve >95% compliance in 2011, and 100% compliance Drug Safety developent activities ASR/DSUR in 2011 Dermatology portfolio.
January 2008 --- January 2010
•Managing the Serious Adverse Event Reporting Process from the first large Clinical Trial GSK BIO (43,000 patients). Ensuring the medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and SAR reports received for the observer-blind safety and latter superior efficacy clinical trial with GSK Biological’s GSK2186877A vaccine in elderly subjects.Management of around 10,000 SAE reports, including SUSARs. -Part of the team, in charge of the preparation of Fluvarix PSUR.
Medical Drug Safety
January 2008 --- January 2008
100 in early and late development oncologic clinical trials. Set up the process for ASRs preparation including SOPs, WI ,templates and training. Authorship of several ASRs. Involved in decision (s) to terminate phase I Clinical trials due to safety. • Guidance in the management and medical assessment of Serious Adverse Event Reporting Process Report of SAEs, SUSARs including case processing and report preparation, follow up, aggregate safety assessment. • Providing medical training on investigational Products. • Responsible for the ongoing safety surveillance • Reviewing Protocols and amendment of protocols. • Provide medical guidance to Pharmacovigilance Managers (PVMs), Clinical Research Physicians (CRPs). • Supporting the Medical Team (CRP) in the preparation /review of protocols, Clinical study Reports, medical support of the PVM team, Data Managers, Project Managers. • Perform the six- monthly MedDRA coding review in the Safety Database ARIS G. • Part of the Team responsible for the reconciliation processes of the Safety DB and the Clinical database. • Review of CTCAE Coding and MedDRA coding • Identification & selection of SPCs (of old chemotherapy drugs) to be used at EORTC as reference document for causality assessment and expectedness assessment. • Ensure the review of Safety Alerts receive at the EORTC • Perform Risk-Benefit Assessment of SUSAR/SUAS and follow -up during the conduct of the studies.
Global Drug Safety Officer
September 2004 --- December 2007
•Global Safety Physician responsible for all safety activities for the phase II first Tibotec in late development compound TMC114 (Darunavir) until approval by the United States Food and Drug Administration (FDA) June 2006 by accelerated procedure, then in EU and Canada as Prezista. •Part of the global TMC 114 compound clinical Team. Working closely with the Clinical leader, US liaison team, Regulatory Affairs team, Biostatistics, Data manager, Medical writers group, external CRO (SGS) and the Benefit Risk Management UK group. •Compiling, review and approval of CMC documentation/data for submissions to INDs & NDA applications. •Serve as a liaison between the BRM (Benefit Risk Management) UK group and Tibotec staff. •Contact person for the Safety Database SCEPTRE at Tibotec. •Review of the data pooled analysis, global database pooling analysis needed for the preparation of Integrated Summaries of Safety Reports.
January 2000 --- August 2004
•Author of around 200 safety documents(Portfolio of Medication delivery): Periodic Safety Update Reports (PSUR), Clinical Expert Statement reports (CES), Addendum to PSUR, Summary Bridging Reports. Update and harmonization safety part of Company Core Data Sheet (CCDS), Local Package Inserts (PILs). .Clinical research Physician at multinational CRO PPD Brussel (2000-2003)
January 1999 --- January 1999
4 days Endoscopy Upper/lower 1 day a week Polyclinic
January 1995 --- July 1998
Fellowship in Pediatrics Gastroenterology (IBD) Prof. Luisa Mearin and Own research project in paediatric Bone Marrow Transplantation (BMT) Unit.
Analytical thinkingAdaptabilityAttention to detailAuthenticityAssertivenessCommunicativeCreative thinkingCuriosityFlexibilityOrganizationInterest in knowledgeProblem solvingResponsibilityResult OrientedStrategic thinkingService orientedTrustWillingness to compromiseSelf-confidenceProactivitySociability
Monoclonal AntibodiesRegulationsActions and modes of action of drugs in the human speciesAuditingBiological Drug DevelopmentCAPAClinical DevelopmentClinical pharmacologyClinical researchClinical Study DesignClinical study reportsClinical trialsCompliance with regulationsCross-functional team leadershipCurrent Good Manufacturing Practice (CGMP)Databases Phase I Scientific writing21 CFR Part 11Adverse Events (AE)Cardiovascular diseasesCoachingDermatologyDiabetesDrug InteractionDrug metabolismDrug Safety and PharmacovigilanceDrug safety assessmentDrug substance developmentGeriatric medicineGood Clinical Practice (GCP)ICH guidelinesImmunologyINDInfectious diseasesInformed Consent DocumentsISO 13485KOL managementLaboratory study designLeadershipmanagementPatentsPatient Follow UpPatient recruitmentPharmacovigilancePhase IPhase IIIPhase IIPhase IVPhases of clinical development (phase I to IV)Pre-clinical researchPreclinical developmentPreclinical SafetyQA complianceQuality AssuranceQuality Assurance (QA)Radiation oncologyRandomization SystemsResearchRisk AssessmentRisk ManagementSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Safety reportingSafety trialsScientific WritingSerious Adverse Event (SAE)Team LeadershipToxicologyUnderstanding of regulatory guidelinesWriting Study Procedures and SOPsVirology
Skills and Expertise
Analytical skills Analyze data Assure medical quality Control data Create SOPs Develop clinical trial protocols Design case record forms Build the CMC development plan Build and manage the Trial Master File (TMF) Interact with physicians Interpret data Lab scale batches Monitor a clinical study Develop protocols Guide students Report data Search literature on clinical trials Technology research Use content management systems Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdjust processes and methods
Fellowship Paediatrics in Paediatrics from Leiden University Medical Center in 1998
Board Certified Gastroenterologist & Hepatologist in Internal Medicine, Gastroenterology, Hepatology, from Université René Descartes (Paris V) in 1994
Master in Oncology in Oncology from Gustave Roussy Institute in 1994
in from Université Paris Sorbonne (Paris IV) in 1992
Doctor in Medicine and Surgery in Medicinr from University Alberto Masferrer in 1989
Training and Certification
HCH- GCP in 2000 Certification
Paediatrics in 1998 Certification
Board Certified Gastroenterologist and Herpetologist in 1994 Certification
Master in Oncology in 1994 Certification
Doctor in Medicine and Surgery in 1989 Certification