Nicole Baker Phd

Nicole Baker Phd Email and Phone Number

CEO at biologit @ biologit
Nicole Baker Phd's Location
County Dublin, Ireland, Ireland
Nicole Baker Phd's Contact Details

Nicole Baker Phd work email

Nicole Baker Phd personal email

n/a
About Nicole Baker Phd

Nicole Baker is the CEO of Biologit, a pioneering technology company specialising in Artificial Intelligence for Active Safety Surveillance. As an Immunologist and Pharmacovigilance Professional, Nicole blends innovative thinking with a profound scientific understanding and extensive global expertise in Medical and Regulatory Affairs, Pharmacovigilance, and Clinical Development.With over 25 years of experience, Nicole has held leadership roles across diverse sectors, including Academia, the Pharmaceutical Industry, Regulatory Authorities, Clinical Research Organisations, and Start-up. She has successfully managed global, multi-disciplinary teams throughout the entire product life-cycle, from pre-clinical stages to post-marketing. Nicole's career highlights include pivotal roles such as EEA QPPV and RPPV in Clinical Trials, and overseeing research and commercial budgets exceeding 100 million.

Nicole Baker Phd's Current Company Details
biologit

Biologit

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CEO at biologit
Nicole Baker Phd Work Experience Details
  • Biologit
    Chief Executive Officer
    Biologit Mar 2020 - Present
    Dublin, County Dublin, Ie
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  • Qppv
    Eea Qppv And Rppv
    Qppv May 2019 - Present
    Dublin, Dublin, Ie
    Services are now offered by biologit.
    View
  • Adapt Centre, Trinity College Dublin
    Commercial Lead
    Adapt Centre, Trinity College Dublin Mar 2020 - May 2021
    Dublin, Ie
    biologit is an ADAPT Centre research team working with Professor Lucy Hederman within Trinity College Dublin, School of Computer Sciences & Statistics. Funded by Enterprise Ireland Commercialisation Fund.
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  • Enterprise Ireland
    New Frontiers Entrepreneur Development Programme Phase 2 Participant
    Enterprise Ireland May 2019 - Nov 2019
    Dublin, Ie
    Developing Artificial Intelligence solutions for Clinical Safety and Pharmacovigilance/Drug Safety.
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  • Besins Healthcare
    Eea Qppv, Head Of Global Pharmacovigilance
    Besins Healthcare Jul 2017 - May 2019
    Monaco, Mo, Mc
    Held the interim position of Head of Global Regulatory Affairs for 6 months.Responsible for Medical and Scientific Information.Reporting to the Board of Directors, responsible for budget and management of department.Providing strategic, operational and scientific leadership and fulfilling the responsibilities of EEA QPPV. Set up the Dublin office: hired, on-boarded and developed internal and external teams. Successfully transitioned pharmacovigilance activities to a new service provider. Successfully implemented new versions and automated the safety database. Implemented and developed quality systems for pharmacovigilance. Integral part of due diligence for new business. Responsible for the safety sections of marketing authorisation applications.
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  • Bioclinica
    Eea Qppv, Global Director Drug Safety And Risk Management
    Bioclinica Apr 2016 - Jul 2017
    Princeton, New Jersey, Us
    Fulfilled the role of EEA QPPV and RP for Pharmacovigilance in Clinical Trials.Set up and implemented pharmacovigilance systems.Responsible for the safety sections of successful new marketing authorisations in the US and EMA.Provided strategic, operational and scientific leadership for clinical, post-marketing and QPPV projects, covering multinational companies with products at various stages of their life-cycle.Successfully actioned Corrective Actions Preventive Actions (CAPAs) as part of an EMA Good Clinical Practice (GCP) inspection and MHRA pharmacovigilance inspection.Integral part of business development services related to drug safety, pharmacovigilance, life sciences consulting and clinical trials, bringing new business and growing existing ones.
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  • Ppd
    Eea Qppv, Associate Director Integrated Safety Services
    Ppd Mar 2015 - Apr 2016
    Wilmington, Nc, Us
    Fulfilled the role of EEA QPPV.Set up and implemented pharmacovigilance systems.Supported clients on diversion and acquisition of new products.Successfully actioned and implemented CAPAs as part of an EMA GCP inspection and MHRA pharmacovigilance inspection.Provided strategy, leadership and operational oversight/input for complex pharmacovigilance services.Won new business in drug safety, pharmacovigilance, life sciences consulting and clinical trials.
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  • Iqvia
    Eea Qppv, Associate Director Customer Delivery Europe
    Iqvia Aug 2013 - Mar 2015
    Durham, North Carolina, Us
    Fulfilled the role of EEA QPPV and RP for Pharmacovigilance in Clinical Trials.Conducted due diligence, set up and implemented pharmacovigilance systems.Supported clients on diversion and acquisition of new products.Responsible for the safety sections of successful new marketing authorisations in the US, EMA and Brazil.Successfully actioned and implemented CAPAs as part of an EMA GCP inspection and FDA pharmacovigilance inspection.Provided strategic, operational and scientific leadership for clinical, post-marketing and QPPV projects, covering multinational companies with products at various stages of their life-cycle.Won new business related to drug safety, pharmacovigilance, life sciences consulting and clinical trials, and further developed existing ones.
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  • Aspen Pharma Group
    Pharmacovigilance Scientist
    Aspen Pharma Group Mar 2012 - Aug 2013
    La Lucia Ridge Umhlanga, Kwazulu Natal, Za
    Supported the set-up of the Dublin office, on-boarded, trained internal teams, set up and implemented pharmacovigilance systems.Lead scientist responsible for cardiology, metabolic, immunology, oncology and inflammation portfolio, supported the EEA QPPV and the PSMF maintenance.Participated in a MHRA/HPRA inspection, and interacted with competent authorities.Responsible for the maintenance of company core safety information and labels, generating and reviewing aggregate reports, signal detection outputs and reports, risk management, literature review, quality review of individual case safety reports, and implementation and maintenance of safety data exchange agreements.
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  • Trinity College Dublin
    Research Fellow And Project Manager
    Trinity College Dublin Feb 2011 - Mar 2012
    Dublin, Ie
    Designed and performed laboratory experiments for the project: Immunomodulatory properties of Helicobacter pylori. Management of project and budget.Teaching and supervising students and junior staff.
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  • Health Products Regulatory Authority (Hpra)
    Safety And Efficacy Assessor
    Health Products Regulatory Authority (Hpra) Jan 2009 - Jan 2010
    Dublin 2, Ie
    Assessment of safety and efficacy aspects of national, decentralised and mutual recognition applications for new immunological products, as well as renewals and variations.Responsible for assessing aggregate reports and risk management plans.Participation in decision making meetings related to applications for immunologicals at EU level.
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  • University College Dublin
    Research Fellow And Project Manager
    University College Dublin May 2007 - Jan 2009
    Dublin, Dublin, Ie
    Designed and performed laboratory experiments for the projects: (A) Lipoxin as a therapeutic candidate for the treatment of Rheumatoid Arthritis. (B) Lipoxin prevents angiogenesis and proliferation in endothelial cells. (C) Testing and validating lipoxin stable analogues for further use in vivo and in vitro. (D) Novel therapies for diabetic nephropathy. Management of project and budget.Teaching and supervising students and junior staff.
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  • Beaumont Hospital
    Medical Scientist
    Beaumont Hospital Jan 2007 - May 2007
    Dublin , Ie
    Provided a nationwide transplant immunology service for solid organ transplantation, including HLA typing, crossmatching donors and recipients for solid organ transplants.
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  • Trinity College Dublin
    Research Fellow And Project Manager
    Trinity College Dublin Jan 2005 - Jan 2007
    Dublin, Ie
    Designed and performed laboratory experiments for the projects: A) Animal models for the development of an effective nasal vaccine for Tuberculosis, HIV and Malaria. (B) Animal models using dentritic cell adoptive transfer for the treatment of Rheumatoid Arthritis and Multiple Sclerosis. Management of project and budget.Teaching and supervising students and junior staff.
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  • University College London
    Research Assistant And Laboratory Manager
    University College London May 2000 - Jan 2005
    London, Greater London, Gb
    Designed and performed laboratory experiments for the projects: (A) Serum IgM deficiency leads to increased susceptibility to Glomerulunephritis. (B) Serum IgM is important for B cell positive selection. (C) Production and characterization of anti-DNA antibodies and its role in Glomerulunephritis. (D) Study of B cells on patients with Lupus or Rheumatoid Arthritis being treated with anti-CD20 or anti-TNF antibodies.Management of project and budget.Teaching and supervising students and junior staff.Maintenance of equipment and overall run of the laboratory.
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  • University Of Tuebingen
    Research Assistant
    University Of Tuebingen Sep 1999 - Jan 2000
    Baden-Württemberg, De
    Designed and performed laboratory experiments for the project: The role of regulatory T cells in animal models of Arthritis.Management of project and budget.Teaching and supervising students and junior staff.
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  • Instituto Butantan
    Research Intern
    Instituto Butantan 1994 - 1999
    Br
    Anoerobic Vaccines Section and Immunogenetic Laboratory
    View

Nicole Baker Phd Skills

Pharmacovigilance Regulatory Affairs Immunology Pharmaceutical Industry Clinical Trials Pharmacology Project Management Vaccines Clinical Development Scientific Writing Medical Writing Meddra Drug Development Clinical Research Biotechnology Pharmaceutics Life Sciences Standard Operating Procedure Arisg Animal Models Risk Management Auditing Inspection Medicine Research Good Clinical Practice Healthcare Patient Safety Quality Assurance Lecturing Strategic Leadership Management Cro Management Argus Safety Good Pharmacovigilance Practice Start Up Ventures Entrepreneurship Artificial Intelligence Medical Affairs Quality System Rheumatology Autoimmunity Big Data Analytics Translational Research

Nicole Baker Phd Education Details

  • University College Dublin
    University College Dublin
    Strategic Growth - Biotech And Pharma Industry
  • University Of London
    University Of London
    Medicine - Rheumatology
  • Usp - Universidade De São Paulo
    Usp - Universidade De São Paulo
    Biomedical Sciences - Immunology
  • Universidade Ibirapuera
    Universidade Ibirapuera
    Biological Sciences - General

Frequently Asked Questions about Nicole Baker Phd

What company does Nicole Baker Phd work for?

Nicole Baker Phd works for Biologit

What is Nicole Baker Phd's role at the current company?

Nicole Baker Phd's current role is CEO at biologit.

What is Nicole Baker Phd's email address?

Nicole Baker Phd's email address is ni****@****ica.com

What schools did Nicole Baker Phd attend?

Nicole Baker Phd attended University College Dublin, University Of London, Usp - Universidade De São Paulo, Universidade Ibirapuera.

What are some of Nicole Baker Phd's interests?

Nicole Baker Phd has interest in Science And Technology, Education, Health.

What skills is Nicole Baker Phd known for?

Nicole Baker Phd has skills like Pharmacovigilance, Regulatory Affairs, Immunology, Pharmaceutical Industry, Clinical Trials, Pharmacology, Project Management, Vaccines, Clinical Development, Scientific Writing, Medical Writing, Meddra.

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