Samsudeen J.M.

Experience

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  Medopharm

  Apr 2017 - May 2017

  Internship Trainee

  Internship done on ORAL SOLID DOSAGE FORM DRUGS.(Warehouse, production, Quality assurance, Packaging departments)

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  Endo

  May 2019 - Aug 2022

  Clinical Research Associate - par biosciences

  CLINICAL RESEARCH ASSOCIATE and PHARMACIST (Clinical R&D division)*Handling of investigational products in bioavailability and bioequivalence studies and in-vitro naso-gastric tube studies.*Reviewing of Protocol, TMF, eCRF and study files.*Ensuring the calibration of instruments in clinical department.* Dispensing and Accountability of investigational products.*Monitoring of study subjects and study activities such as sample collection ,centrifugation, processing and seggregation.*Investigational product dosing to subject.ICD and ICF distribution. obtain consent from volunteers.*Reviewing of SOP's and updating it as per NDCT rules.*Handling electronic software s like Alphadas(eCRF), Lims,Trackwise, VPMS etc., Show less

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  Pfizer

  Aug 2022 - now

  *To collect the required and relevant data for the respective manufacturing sites. To complete requirements for Post approval changes.*Maintaining life cycle management of Commercial products, regarding the status of regulations with global health authorities.*To evaluate and updating of clinical data as per the global health authority requirement.*Ensuring compliance and delivering efficiencies in the regulatory submission process.*Managing queries from Global Health Authorities.*Ensuring updates for the following Pfizer system:Working with software like PDM (Product Dossier Manger), Track wise, PEARL, COMPASS, I-Plan, and GDMS Show less

  • Associate II Regulatory conformance -PLMDS

    Jun 2023 - now

  • Regulatory conformance associate - PLMDS

    Aug 2022 - May 2023