Julia Malko

FAQ About Julia Malko

• What is Julia Malko's address?

  Julia Malko is located at
  Vaughan, Vaughan, Canada

• What is Julia Malko's job title?

  Julia Malko is a
  • Canadian Equivalency in Medical Degree approved by ICAS organization, Clinical Research Associate Certified Diploma in ICH GCP and Monitoring of Clinical Trial. • Highly Professional and Experienced in Management of Conduction, Monitoring and Completion of clinical trials all phases inclusive (phase I to phase IV) according to ICH GCP guidelines, FDA/TPD expectations as well as Sponsor Expectation. • Exceptional Knowledge and Experience on Safety Reports including Assessment of Seriousness Criteria, Relatedness Criteria of clinical trials according to ICH GCP guidelines and TPD/FDA expectations. • Processed Adverse event reports from clinical trials and from marketing activities as per company SOPs and guidelines for maintaining regulatory compliance. • Review Serious Adverse Event/Adverse Events on Expectedness Criteria according to Investigational Brochure. • Medical and Clinical guidance to Study managers before, throughout, and following clinical trials. • Creation and Generation Serious Adverse Events/Adverse Events related documents in alliance with Regulatory Requirements/Company Policies. • Management of consistency of safety assessments and in case of inconsistency perform follow up. • Ensure Regulatory Compliance and Safety of Subjects throughout trial. • Experience on Submission of Periodic reports to the Food and Drug Administration. • Knowledge of Medical Terminology and Experience with MedDRA and WHO regulations. • Excellent Data Review for Completeness Criteria, Consistency and Legibility as well as Medical Point review according to particular clinical trial interest. • Exposure to variety of Therapeutic areas in Clinical Research studies. • Excellent time management and ability to prioritize in Right Direction while working in Fast Speed Environment. • Ability to work effectively in a Team/matrix Environment as well as Leadership Skills. University Health Network

• What industry does Julia Malko currently work in?

  Julia Malko currently works in the
  University Health Network

• What is Julia Malko's area of expertise?

  Julia Malko specializes in
  • Canadian Equivalency in Medical Degree approved by ICAS organization, Clinical Research Associate Certified Diploma in ICH GCP and Monitoring of Clinical Trial. • Highly Professional and Experienced in Management of Conduction, Monitoring and Completion of clinical trials all phases inclusive (phase I to phase IV) according to ICH GCP guidelines, FDA/TPD expectations as well as Sponsor Expectation. • Exceptional Knowledge and Experience on Safety Reports including Assessment of Seriousness Criteria, Relatedness Criteria of clinical trials according to ICH GCP guidelines and TPD/FDA expectations. • Processed Adverse event reports from clinical trials and from marketing activities as per company SOPs and guidelines for maintaining regulatory compliance. • Review Serious Adverse Event/Adverse Events on Expectedness Criteria according to Investigational Brochure. • Medical and Clinical guidance to Study managers before, throughout, and following clinical trials. • Creation and Generation Serious Adverse Events/Adverse Events related documents in alliance with Regulatory Requirements/Company Policies. • Management of consistency of safety assessments and in case of inconsistency perform follow up. • Ensure Regulatory Compliance and Safety of Subjects throughout trial. • Experience on Submission of Periodic reports to the Food and Drug Administration. • Knowledge of Medical Terminology and Experience with MedDRA and WHO regulations. • Excellent Data Review for Completeness Criteria, Consistency and Legibility as well as Medical Point review according to particular clinical trial interest. • Exposure to variety of Therapeutic areas in Clinical Research studies. • Excellent time management and ability to prioritize in Right Direction while working in Fast Speed Environment. • Ability to work effectively in a Team/matrix Environment as well as Leadership Skills.

• Which languages does Julia Malko speak? 

  Julia Malko speaks the following languages:
  No languages available.

• Which industries has Julia Malko previously worked in?   

  Julia Malko has prior experience in the following industries:
  Axiom Real Time Metrics , Medstrat , Roche , Biorasi , Zm Company Cro , Osprey Pharmaceutical , Credit Valley Hospital

• What is Julia Malko’s work experience?  

  Julia Malko has the following professional experience:
  University Health Network , University Health Network , Axiom Real Time Metrics , Medstrat , Roche , Biorasi , Zm Company Cro , Osprey Pharmaceutical , Credit Valley Hospital .

• How can I find Julia Malko on LinkedIn?  

  You can view Julia Malko’s
  LinkedIn profile at LinkedIn URL.

• What are Julia Malko’s work email addresses?  

  Julia Malko’s work email addresses are
  [email protected] .

• What company does Julia Malko work for?  

  Julia Malko works at
  University Health Network