Kalyani Sharma

Kalyani Sharma

Clinical Research Coordinator

Clinical research and pharmacy professional experienced in pharmacovigilance, safety case processing, and regulatory documentation. Skilled in supporting clinical trials, TMF reconciliation, and protocol compliance while ensuring participant safety and ethical research conduct.

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10

Years of experience

Kalyani

About Me

Clinical research and pharmacovigilance professional with a strong background in safety case management, regulatory documentation, and clinical trial support. Experienced in managing ICSR processing, TMF reconciliation, audit readiness, and regulatory submissions across global frameworks including FDA, EMA, and Health Canada. Skilled in clinical systems such as CTMS, eTMF, and EMR while maintaining compliance with ICH-GCP, TCPS2, and PIPEDA guidelines. Dedicated to ensuring ethical research conduct, accurate documentation, and participant safety in clinical research environments.

My expert
areas

Expertise in clinical documentation, pharmacovigilance, safety case processing, regulatory submissions, participant coordination, and audit readiness while supporting clinical trials with strong compliance to global regulatory frameworks.

Skills

Clinical Data Verification & Documentation

Participant Screening & Study Coordination

Pharmacovigilance & Safety Case Processing

Regulatory & Ethics Submissions

CTMS, eTMF & EMR Clinical Systems

Audit Readiness & Quality Compliance

  • 10000

    Processed Safety Cases (ICSRs Managed)
  • 150

    Clinical Prescriptions Documented (Weekly)
  • 2000

    Medication Inventory Managed
  • 500

    Adverse Event Cases Handled

Education

Post-Graduate Diploma in Clinical Research, Pharmacovigilance & Regulatory Affairs
Academy of Applied Pharmaceutical Sciences
Canada
January 2025 - December 2025
Postgraduate Degree in Health Care Administration & Management
Northern College of Applied Arts and Technology
Canada
May 2023 - January 2024
Master of Pharmacy (M.Pharma) in Pharmaceutical Sciences
Uttarakhand Technical University
Dehradun, India
August 2018 - October 2020
Bachelor of Pharmacy (B.Pharma)
Maharshi Dayanand University
India
July 2009 - June 2013

Experience

Certifications

Projects

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