Summary
Overview
Work History
Education
Skills
Training
Professional Skills
Timeline
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Diksha Rani

Norval

Summary

Detail-focused individual with a strong foundation in pharmaceutical sciences, committed to ensuring drug safety. Knowledgeable about drug safety regulations, adverse event reporting, lab techniques, and document management. Keen ability to analyze clinical data and identify potential safety concerns. Dedicated to contributing to patient safety and enhancing the overall quality of healthcare through diligent monitoring and reporting.

Overview

5
5
years of professional experience

Work History

Trial Master File Document Specialist

Syneos Health
06.2023 - 12.2023
  • Managed compliance and documentation for pharmaceuticals as TMF Document Specialist.
  • Processed study documentation according to ICH-GCP principles and SOPs, fulfilling research needs.
  • Established and maintained TMF repositories, improving data organization.
  • Executed quality control measures, including indexing and document scanning, to enhance operational efficiency.
  • Supported audits and inspections to ensure regulatory compliance within pharmaceutical environments.
  • Facilitated training sessions to enhance team proficiency in TMF processes.
  • Optimized and enforced consistent document management policies for improved adherence.
  • Organized and safeguarded files and databases while maintaining records of all scanned documents.

Microbiology Technologist

Leom Multicare Hospital
06.2019 - 05.2023
  • Supported quality assurance initiatives within the organization by participating in proficiency testing programs and maintaining accurate records of test results.
  • Reduced contamination risks by maintaining a clean and organized work environment.
  • Maintained high-quality control standards by conducting regular audits of equipment, reagents, and processes.
  • Provided expert guidance to junior technologists on best practices for microbiology testing and specimen handling.
  • Evaluated the efficacy of antibiotics against bacterial strains using susceptibility testing methods like disk diffusion and broth microdilution assays.

Education

Post Graduate Diploma - Clinical Research, Pharmacovigilance and Regulatory Affairs

Academy of Applied And Pharmaceutical Sciences
09-2025

Master of Science - Microbial Biotechnology

Panjab University
Chandigarh, India
08-2022

Bachelor of Science - Microbiology

Panjab University
Chandigarh, India
05-2019

Skills

    Problem solving ability

    Leadership qualities

    Excellent Communication Skills

    Creative and logical

    Perseverant

    Observation skills

    Strong belief in professionalism

    Flexible and responsible

    Ability to prioritize tasks

Training

Drug Safety Associate Trainee at Academy of Clinical Intelligence, Mohali (Aug 2022- Dec 2022)


  • Processed over 60 cases from diverse sources, including Spontaneous and Literature cases
  • Acquired expertise in assessing seriousness, expectedness, and causality of adverse events
  • Demonstrated comprehensive understanding of ICH and GVP guidelines
  • Utilized skills in Narrative Writing and MedDRA for effective case documentation.

Professional Skills

  • Document management and security
  • Regulatory compliance and GCP
  • Quality assurance and review
  • Attention to details
  • Problem-solving and multitasking
  • Electronic filing systems
  • Risk management strategies
  • Veeva Vault expertise
  • Timely document delivery
  • Adverse event reporting
  • Sample Collection and Handling
  • Lab Techniques

Timeline

Trial Master File Document Specialist

Syneos Health
06.2023 - 12.2023

Microbiology Technologist

Leom Multicare Hospital
06.2019 - 05.2023

Post Graduate Diploma - Clinical Research, Pharmacovigilance and Regulatory Affairs

Academy of Applied And Pharmaceutical Sciences

Master of Science - Microbial Biotechnology

Panjab University

Bachelor of Science - Microbiology

Panjab University

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Diksha Rani