Dr. Madhu BC-MSLcert, PharmD, MS(Onc)

Board Certified MSL at from SCIENCE to PHARMA (FSTP) - Board Certified MSL training
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Contact Information
us****@****om
(386) 825-5501
Location
Berlin, Berlin, Germany, DE
Languages
  • English Full professional proficiency
  • German Limited working proficiency
  • Italian Professional working proficiency

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Credentials

  • Board certified MSL
    from SCIENCE to PHARMA (FSTP) - Board Certified MSL training
    May, 2023
    - Nov, 2024
  • MDR 2017/745
    Udemy
    Oct, 2022
    - Nov, 2024
  • Medical device validation
    Udemy
    Oct, 2022
    - Nov, 2024
  • GMP
    Udemy
    Aug, 2022
    - Nov, 2024
  • Pharmacovigilance
    Uppsala Monitoring Centre
    Aug, 2022
    - Nov, 2024
  • ADR Reporting
    The Global Health Network
    Apr, 2022
    - Nov, 2024
  • Drug Regulatory Affairs
    Udemy
    Mar, 2022
    - Nov, 2024
  • Registered clinical pharmacist
    Pharmacy Council of India
    Jul, 2019
    - Nov, 2024
  • Board Certified Pharmacotherapy Specialist (BCPT)
    Apollo Hospitals
    Jul, 2018
    - Nov, 2024
  • Board Certified Pharmacotherapy Specialist (BCPT)
    Apollo Hospitals
  • Board certified MSL
    from SCIENCE to PHARMA (FSTP) - Board Certified MSL training
  • ICH GCP
    The Global Health Network

Experience

    • Australia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Board Certified MSL
      • Jun 2023 - Present

    • Medical Science Liaison Fellowship
      • May 2023 - Jul 2023

  • Ospedale Maggiore Novara
    • Novara, Piedmont, Italy
    • Clinical Scientist
      • Mar 2022 - May 2023

      Implemented and Analysed Clinical Trials. •Collaborated with other Scientists, Clinicians and Regulatory agencies to ensure compliance with Ethical and Regulatory Guidelines. •Prepared and provided inputs to Clinical Study Reports & Regulatory documents. Acted as liaison to cross-functional project team, CROs, study sites. •Established relationships with KOLs, investigators and appropriate consultants. Implemented and Analysed Clinical Trials. •Collaborated with other Scientists, Clinicians and Regulatory agencies to ensure compliance with Ethical and Regulatory Guidelines. •Prepared and provided inputs to Clinical Study Reports & Regulatory documents. Acted as liaison to cross-functional project team, CROs, study sites. •Established relationships with KOLs, investigators and appropriate consultants.

    • Clinical Regulatory Affairs Trainee
      • Mar 2022 - Jul 2022

      Trained in preparation of IND, MAA •SOP review and development •Labelling for Medicines, Patient information leaflets (PILs) •Warning on labels and leaflets for medicines •Experienced in Module 1 & 5 of Common technical document. •Preparation of SmPC and Prescribing information •Knowledge of labelling requirements for IMP •Overview of Marketing authorisation application Trained in preparation of IND, MAA •SOP review and development •Labelling for Medicines, Patient information leaflets (PILs) •Warning on labels and leaflets for medicines •Experienced in Module 1 & 5 of Common technical document. •Preparation of SmPC and Prescribing information •Knowledge of labelling requirements for IMP •Overview of Marketing authorisation application

    • Associate Research Fellow
      • Jan 2020 - Jan 2022

      Conducted Literature Reviews and summarised Research findings. •Collected, Analysed and Reported Data related to Health trends & issues. •Developed Model Care Pathway for Myasthenia Gravis using Delphi studies in collaboration with UCB Pharma Conducted Literature Reviews and summarised Research findings. •Collected, Analysed and Reported Data related to Health trends & issues. •Developed Model Care Pathway for Myasthenia Gravis using Delphi studies in collaboration with UCB Pharma

    • India
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Clinical Safety Specialist
      • Jul 2018 - Aug 2019

      Assessed and Reviewed Adverse Event data.•Interfaced with CROs, Project team and Trial sites.•Trained others on Safety related topics Internally and Externally. •Developed Safety Monitoring Plans and Periodic Safety Reports. •Monitored all AEs, SAEs and MAE occurring in pre&post approval Clinical studies.

    • Licensed Clinical Pharmacist
      • Dec 2017 - Jun 2018

      Monitored Drug therapy regimens.•Attended and actively participated in daily multidisciplinary and bedside rounds.•Worked with medical staff to promote Rational Drug Therapy. •Prevented and resolved Drug related problems to ensure safety and efficacy.•Documented Clinical activities and ADRs.

    • Drug Safety Associate
      • Feb 2016 - May 2017

      Follow up on important c case reports and drug interactions. •Served as a link between Company and the Patients/Healthcare experts to provide Product Safety Information. •Added value to the company through product safety functionality. Follow up on important c case reports and drug interactions. •Served as a link between Company and the Patients/Healthcare experts to provide Product Safety Information. •Added value to the company through product safety functionality.

Education

  • UNIUPO
    Master's degree, Medical Biotechnology (Oncology)
    2019 - 2022
  • Jawaharlal Nehru Technological University
    Doctor of Pharmacy - PharmD, Medicine
    2012 - 2018

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