Experience

Byondis

• Netherlands
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Medical Safety Advisor

  • May 2022 - Present

  Responsible for PSMF, RMP and SmPC in close cooperation with the CMO and Pharmaceutical & Trial Specialist Responsible for PSMF, RMP and SmPC in close cooperation with the CMO and Pharmaceutical & Trial Specialist



Minervax ApS

• Denmark
• Biotechnology
• 1 - 100 Employee

• Sr. Pharmacovigilance Manager

  • Apr 2022 - Present

  Responsible for Safety Reporting Process and related activities Responsible for Safety Reporting Process and related activities



PharmaLex

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Pharmacovigilance Manager

  • Sep 2021 - Present

  Performing Consultancy Assignments Servicing and execution of purchase orders (Project Contracts) Performing Consultancy Assignments Servicing and execution of purchase orders (Project Contracts)



Julius Clinical

• Netherlands
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Global Safety Physician

  • Jul 2021 - Apr 2022

  Assisting ALS project Preparation PV related documents Assisting ALS project Preparation PV related documents



IO Biotech

• Denmark
• Biotechnology Research
• 1 - 100 Employee

• Sr. Pharmacovigilance Lead

  • May 2020 - Apr 2022

  Giving advice on Pharmacovigilance in a starting Biotech company producing cancer vaccins used as therapeutics since 5 years Evaluation of the PV system and related safety topics Involved in the IO's technology platform Giving advice on Pharmacovigilance in a starting Biotech company producing cancer vaccins used as therapeutics since 5 years Evaluation of the PV system and related safety topics Involved in the IO's technology platform



Mithra

• Belgium
• Biotechnology Research
• 100 - 200 Employee

• Pharmacovigilance Specialist

  • Feb 2021 - Sep 2021

  Assisting in the assessment/validation/submission of ICSRs and PV related documents (PBRER, PSURs,RMPs etc) Supporting with the preparation and execution of safety related documents Assisting in the assessment/validation/submission of ICSRs and PV related documents (PBRER, PSURs,RMPs etc) Supporting with the preparation and execution of safety related documents



Arriello

• Ireland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Principal Consultant

  • Mar 2021 - Apr 2021

  Temporarily, assisting the PV departement Ensure product and market practices are well developed in as much a way that quality and efficiency of the organization is promoted Temporarily, assisting the PV departement Ensure product and market practices are well developed in as much a way that quality and efficiency of the organization is promoted



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Safety Physician

  • Dec 2020 - Apr 2021

  Preparation of CSR and review/execution of medical narratives Supporting with preparation of safety related documents (i.e. PSURs, DSURs etc.) Preparation of CSR and review/execution of medical narratives Supporting with preparation of safety related documents (i.e. PSURs, DSURs etc.)



Piramal Group

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• International QPPV a.i.

  • Jul 2020 - Dec 2020

  Executing the responsibilities of a Global QPPV Ensuring the compliance of safety reporting of the products used in critical care produced by Piramal Executing the responsibilities of a Global QPPV Ensuring the compliance of safety reporting of the products used in critical care produced by Piramal



AGFA Healthcare NV

• Mortsel, Flemish Region, Belgium

• QUARA BD IMG Vigilance

  • Jan 2019 - Feb 2020

  Preparation Clinical Evaluation Reports of Medical Devices (Radiologic solutions) according to the EMA Legislation Medical Devices Medical Lead of Clinical Evaluation Team (n=6) Lead Auditor Notified Body February 2020 Preparation Clinical Evaluation Reports of Medical Devices (Radiologic solutions) according to the EMA Legislation Medical Devices Medical Lead of Clinical Evaluation Team (n=6) Lead Auditor Notified Body February 2020



SGP Pharma Supply

• Hospitals and Health Care

• Senior Auditor

  • Oct 2019 - Nov 2019

  Performed GPV Audit at Service Provider Preparation of Response Document and Audit Report Performed GPV Audit at Service Provider Preparation of Response Document and Audit Report



CSL Behring GmbH

• Marburg an der Lahn, Hesse, Germany

• Global Deputy QPPV

  • Nov 2017 - Dec 2018

  Performed the role of a Deputy EU-QPPV with global extension. Twenty-five employees reporting. Involved in Vendor Audit-responsible for the evaluation of assessment and submission of SAEs IMP. Responsible for the validation/approval of ICSR's of a Global Oncology Study. Accountable for the renewal of a study design (C1-inhibitor) Performed the role of a Deputy EU-QPPV with global extension. Twenty-five employees reporting. Involved in Vendor Audit-responsible for the evaluation of assessment and submission of SAEs IMP. Responsible for the validation/approval of ICSR's of a Global Oncology Study. Accountable for the renewal of a study design (C1-inhibitor)



Cesra

• United States
• 1 - 100 Employee

• Senior Auditor

  • Nov 2017 - May 2018

  Executed GCP Audit at CRO and GPV Audit at Service Provider. Evaluated the Vendor oversight at the CRO. Preparation of Response Documents and Audit Reports Executed GCP Audit at CRO and GPV Audit at Service Provider. Evaluated the Vendor oversight at the CRO. Preparation of Response Documents and Audit Reports



PRA Health Sciences (CRO)

• Mannheim, Duitsland

• Medical Director Pharmacovigilance, Medical Affairs

  • Apr 2016 - Nov 2017

  Contributing to RFP's by using critical success factors and providing options for different approaches for patient recruitment, referral systems and operational execution. Attends BID defense meetings, generation of presentations, active role in RFP discussions with clients. Active involvement in scientific meetings. Providing support in all facets of clinical trial management, regulatory submissions, Pharmacovigilance, OPPV positions and professional services. Contributing to RFP's by using critical success factors and providing options for different approaches for patient recruitment, referral systems and operational execution. Attends BID defense meetings, generation of presentations, active role in RFP discussions with clients. Active involvement in scientific meetings. Providing support in all facets of clinical trial management, regulatory submissions, Pharmacovigilance, OPPV positions and professional services.



uniQure (Biotech)

• Amsterdam Area, Netherlands

• Pharmacovigilance Physician

  • Oct 2015 - Mar 2016

  Monitor and assess the SAE;s of gentherapy Haem B and LPLD Interim project to structure the PV department and align with the EMA PV guidelines Initiation and responsible for the organisation/exectution of the Dutch Safety Council and the Data Monitoring Commitee Main role at internal and external drug safety audit of service provider Monitor and assess the SAE;s of gentherapy Haem B and LPLD Interim project to structure the PV department and align with the EMA PV guidelines Initiation and responsible for the organisation/exectution of the Dutch Safety Council and the Data Monitoring Commitee Main role at internal and external drug safety audit of service provider



CSL Behring

• United States
• Biotechnology Research
• 700 & Above Employee

• Global Pharmacovigilance Expert

  • Feb 2015 - Oct 2015

  GAP analysis retrospective reconciliation of NIS, PASSs and IISs due to the MHRA inspection september 2014 (>1000 ICSRSs) Preparation and execution of PV SOPs to align with the EMA PV guidelines GAP analysis retrospective reconciliation of NIS, PASSs and IISs due to the MHRA inspection september 2014 (>1000 ICSRSs) Preparation and execution of PV SOPs to align with the EMA PV guidelines



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Global Safety Manager

  • Jan 2015 - Aug 2015

  Preparation of Aggregated Reports, Health Hazzard Assessments and RMPs Support medical evaluation of Adverse Events and the Literature Group TA's: Neurology, Psychiatry, CV, Pulmonology, Oncology, Immunology and Endocrinology Preparation of Aggregated Reports, Health Hazzard Assessments and RMPs Support medical evaluation of Adverse Events and the Literature Group TA's: Neurology, Psychiatry, CV, Pulmonology, Oncology, Immunology and Endocrinology



Admeda Arzneimittel GmbH

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmacy Physician

  • Dec 2014 - May 2015

  Preparation and execution RMP of local product Preparation and execution RMP of local product



Vigilex

• home-based

• Global Pharmacovigilance Expert

  • Feb 2015 - Apr 2015

  Medical and safety analysis of SAE;s on request of the MHRA Medical and safety analysis of SAE;s on request of the MHRA



Pierre Fabre Group

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Safety Manager

  • Sep 2014 - Jan 2015

  Managing daily issues of Oncology products Preparation and execution RMPs Oncology products Implementation safety part in the Clinical Renewal, PRAC recommendations in SPmC Five reporting PVA's Managing daily issues of Oncology products Preparation and execution RMPs Oncology products Implementation safety part in the Clinical Renewal, PRAC recommendations in SPmC Five reporting PVA's



Pharming Group N.V.

• Biotechnology Research
• 400 - 500 Employee

• Pharmacovigilance Physician

  • Jan 2014 - Aug 2014

  GAP analysis PV department Updated/revised all PV related documents Assisted with Inspection Dutch Health Inspectorate Prepared and executed CAPA Ensured safety responsibilities of licensed and distributed companies in the SDEA's Performed with RA audits at licensed and distributed companies Training Inspection readiness for all employees GAP analysis PV department Updated/revised all PV related documents Assisted with Inspection Dutch Health Inspectorate Prepared and executed CAPA Ensured safety responsibilities of licensed and distributed companies in the SDEA's Performed with RA audits at licensed and distributed companies Training Inspection readiness for all employees



Bilthoven Biologicals (Vaccin producer)

• De Bilt, The Netherlands

• Pharmacovigilance Physician, QPPV

  • Dec 2013 - May 2014

  GAP-analysis regarding PV department Due diligence service provider Preparation and execution of PV SOPs and RMP (line extension vaccin) Training RA manager on EMA guidelines GAP-analysis regarding PV department Due diligence service provider Preparation and execution of PV SOPs and RMP (line extension vaccin) Training RA manager on EMA guidelines



Crucell Vaccines

• Bern Area, Switzerland

• Global Pharmacovigilance Manager Compliance

  • Jul 2013 - Dec 2013

  Ensuring compliance during transfer of all vaccines SOP's due to the merge of Crucell with JJ Completed outstanding MHRA CAPA's Safety screening and preparation of Safety Reports Preparation and delivery of PSURs, PBERs and RMPs per vaccin Training of PV related documents to the medical, PV and RA employees Ensuring compliance during transfer of all vaccines SOP's due to the merge of Crucell with JJ Completed outstanding MHRA CAPA's Safety screening and preparation of Safety Reports Preparation and delivery of PSURs, PBERs and RMPs per vaccin Training of PV related documents to the medical, PV and RA employees



Nutricia

• Netherlands
• Hospitals and Health Care
• 700 & Above Employee

• Global Medical and Pharmacovigilance Monitor

  • Jul 2012 - Oct 2013

  Responsible for medical and safety monitoring-improvement SAE register Prepared business plan for- Safety Database Input safety in Clinical Protocols Prepared Benefit-Risk and Safety review reports for several food products Responsible for coding and replacing WHO-art by MedDRA codes Training medical/clinical, DM and safety team Responsible for medical and safety monitoring-improvement SAE register Prepared business plan for- Safety Database Input safety in Clinical Protocols Prepared Benefit-Risk and Safety review reports for several food products Responsible for coding and replacing WHO-art by MedDRA codes Training medical/clinical, DM and safety team



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Risk Manager

  • Oct 2012 - Jun 2013

  Global Safety screening and data mining (review ICSRs, Global Literature, Signal Detection) Preparation and delivery of Risk Management Reports (Respiratory, Neurology and Immunology) Updating CCDS, preparation of PSURs and PBERs Global Safety screening and data mining (review ICSRs, Global Literature, Signal Detection) Preparation and delivery of Risk Management Reports (Respiratory, Neurology and Immunology) Updating CCDS, preparation of PSURs and PBERs



ProFibrix, Inc.

• The Netherlands

• Pharmacovigilance Physician

  • Sep 2012 - Jun 2013

  Preparation and execution of Service Provider USA to The Netherlands Preparation of PSMF and RMP (of scratch) Training employees of SOPs and PV documents Preparation and execution of Service Provider USA to The Netherlands Preparation of PSMF and RMP (of scratch) Training employees of SOPs and PV documents



Abbott Germany

• Hannover Area, Germany

• Global Pharmovigilance Physician

  • Jul 2012 - Oct 2012

  Project preparation/adaptation of SDEAs due to the transfer of contracts of AbVie (USA) to Abbott Europe (EEA) Project preparation/adaptation of SDEAs due to the transfer of contracts of AbVie (USA) to Abbott Europe (EEA)



CSL Behring

• United States
• Biotechnology Research
• 700 & Above Employee

• Global Pharmacovigilance Physician

  • Mar 2012 - May 2012

  Re-assessment of cases (due to merge-six safety databases with different definitions) Re-assessment of cases (due to merge-six safety databases with different definitions)



Otsuka Pharmaceutical Companies Europe

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Global Pharmacovigilance Physician

  • Mar 2012 - May 2012

  CAPA-outstanding major findings MHRA inspection Preparation of response documents, SOP's, templates updates (new EMA PV guidances) CAPA-outstanding major findings MHRA inspection Preparation of response documents, SOP's, templates updates (new EMA PV guidances)



Sanquin

• Netherlands
• Hospitals and Health Care
• 700 & Above Employee

• Head of PV department, QPPV

  • May 2010 - Mar 2012

  CAPA related to critical and major findings Dutch Health Inspectorate After completion CAPA-Initiated and execution of succesfull PV audit Training employees on Inspection preparation and medical and PV SOP's CAPA related to critical and major findings Dutch Health Inspectorate After completion CAPA-Initiated and execution of succesfull PV audit Training employees on Inspection preparation and medical and PV SOP's



Astellas Pharma US

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Director Pharmacovigilance-QPPV

  • Aug 2008 - Aug 2010

  Lead of Global Project for full program of submission urology product (Block-Buster) in USA, Japan and EU (team of 6 members) KOL, Advisory Board meetings, training. Line manager 6 members in EU, Japan and USA. Lead of Global Project for full program of submission urology product (Block-Buster) in USA, Japan and EU (team of 6 members) KOL, Advisory Board meetings, training. Line manager 6 members in EU, Japan and USA.



Smelt

• Netherlands
• Staffing and Recruiting
• 1 - 100 Employee

• Trainer reporting (S)AE's in clinical trials

  • Oct 2008 - Jun 2009

  Workshop for CRA's Workshop for CRA's



Genzyme Europe B.V.

• Netherlands
• Biotechnology Research
• 100 - 200 Employee

• Medical Director Pharmacovigilance, Deputy QPPV

  • Apr 2007 - Aug 2008

  Responisible for CRD Orphan and Psychiatric/Neurology Drugs. RMP's, Clinical Protocols and Study Reports, Safety Data Reports. Line-manager of 6 employees. Training SOPs (medical and PV). Responisible for CRD Orphan and Psychiatric/Neurology Drugs. RMP's, Clinical Protocols and Study Reports, Safety Data Reports. Line-manager of 6 employees. Training SOPs (medical and PV).



Merck-Serono

• The Hague Area, Netherlands

• Local Drug Safety and Pharmacovigilance Officer Benelux

  • Sep 2006 - Mar 2007

  Interim project due to illness. Revision PV system and related document, preparation RMP. Trial applications CCMO Interim project due to illness. Revision PV system and related document, preparation RMP. Trial applications CCMO



Tibotec Pharmaceuticals

• Ireland
• Financial Services

• PV Physician

  • Jan 2006 - Jan 2007

  Validation of HIV data for submission Validation of HIV data for submission



Novartis Oncology

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical Advisor Oncology

  • Apr 2006 - Aug 2006

  Interim project due to illness Preparation submission file, initiation and execution Compassionate Use Program Training account managers Interim project due to illness Preparation submission file, initiation and execution Compassionate Use Program Training account managers



Glaxo Smith Kline Biologicals

• Brussels Area, Belgium

• Global PV Manager Vaccines

  • Oct 2005 - May 2006

  Project to prepare submission Rotarix Member Advisory Board Cervarix (HPV vaccin) Project to prepare submission Rotarix Member Advisory Board Cervarix (HPV vaccin)



AM-Pharma, biotechnology

• The Netherlands

• Medical Director and PV manager, QPPV

  • Apr 2004 - Sep 2005

  Initiation of Medical and PV department. Responsible for initiation and execution of clinical development (animal/simulation, Phase 1-3). Initiation of Medical and PV department. Responsible for initiation and execution of clinical development (animal/simulation, Phase 1-3).



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assistent Medical Director and Clinical Research Physician

  • Sep 2001 - Mar 2004



Yamanouchi

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Medical Affairs Manager Europe

  • Feb 1998 - Aug 2001

  Responsible for full clinical development (Ph 1-4) and commercialisation plan (corporate & local). Medical device (administration of Interferon). Responsible for compound training, KOL and Advisory Board meetings, publications of PI's. Line manager of EU-affiliates (6 teams). Responsible for full clinical development (Ph 1-4) and commercialisation plan (corporate & local). Medical device (administration of Interferon). Responsible for compound training, KOL and Advisory Board meetings, publications of PI's. Line manager of EU-affiliates (6 teams).