Kalyani Sharma
Clinical Research & Drug Safety Professional
Clinical research, pharmacovigilance, drug safety, and QA documentation professional with 7+ years of experience across clinical support, safety case processing, and regulatory compliance. Strong expertise in ICSR lifecycle management, audit readiness, TMF reconciliation, and quality-driven documentation.
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7
Years of experience
Kalyani
About Me
Clinical research, pharmacovigilance, drug safety, and QA documentation expertise developed through experience in safety case processing, regulatory submissions, audit readiness, and GMP-based documentation control. Strong capability in ICSR lifecycle management, adverse event reporting, TMF reconciliation, batch record review, informed consent review, and protocol compliance across CTMS, eTMF, EMR, and GMP environments. Focus on patient safety, regulatory accuracy, ethical research conduct, and quality-driven clinical operations.
My expert
areas
Expertise across clinical research, pharmacovigilance, drug safety operations, QA documentation, regulatory compliance, audit readiness, and safety-focused data management within healthcare and pharmaceutical environments.
Skills
Clinical Data Verification & Documentation
Participant Screening & Study Coordination
Pharmacovigilance & Safety Case Processing
Regulatory & Ethics Submissions
Clinical Systems (CTMS, eTMF, EMR)
Audit Readiness & Quality Compliance
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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
Shifa Pharmacy
Pharmacy Assistant | June 2024 – January 2025
- Processed and documented 150+ prescriptions weekly in EMR systems, maintaining 99% accuracy and compliance with provincial documentation standards.
- Resolved 40+ insurance claim rejections monthly, improving billing turnaround by 25% and reducing patient wait times by 20%.
- Conducted monthly audits of 2,000+ medication units, reducing expired stock losses by 18% through monitoring and documentation controls.
- Guided 60+ patients weekly on dosage schedules, contraindications, and refill coordination, improving medication adherence rates by 22%.
- Identified and escalated 15+ potential adverse drug reactions to pharmacists, supporting pharmacovigilance compliance and patient safety oversight.
PharmaLex India Pvt. Ltd. (Cencora)
Drug Safety Associate | March 2021 – April 2023
- Processed 10,000+ ICSRs involving MedDRA coding, seriousness assessment, and narrative writing, ensuring high-quality and compliant safety documentation.
- Managed full ICSR lifecycle including triage, duplicate checks, follow-ups, and validation, reducing average case processing time by 15%.
- Executed quarterly literature surveillance and reconciled 2,000+ safety records to support signal detection and aggregate reporting activities.
- Facilitated TMF reconciliation and supported site activation documentation, ensuring 96% audit readiness during sponsor and internal inspections.
Academy of Clinical Intelligence (ACI)
Pharmacovigilance Trainee | June 2020 – February 2021
- Performed triage and structured data entry of 500+ adverse event cases, ensuring accuracy and compliance under team supervision.
- Coordinated safety timeline monitoring and regulatory follow-ups, improving documentation tracking efficiency by 20% across reporting activities.
- Analyzed audit reviews of informed consent forms and safety documentation, identifying 25+ compliance gaps for corrective action.
- Prepared AE listings and reconciled 20+ reports supporting signal detection, evaluation processes, and documentation review activities.
Sujay Life Sciences
Pharmacy Associate | August 2014 – August 2017
- Dispensed 300+ pharmaceutical units daily under GMP protocols, maintaining compliance with safety, handling, and documentation requirements.
- Managed labeling, storage, and documentation for 1,500+ SKUs, ensuring adherence to regulatory and quality standards.
- Assessed QA documentation logs and material records supporting 5+ internal quality inspections with accurate reporting practices.
- Ensured adherence to safety protocols and documentation accuracy, contributing to zero major audit findings across operations.
Ranbaxy Labs Ltd.
Quality Analyst | August 2013 – August 2014
- Executed quality control testing of 200+ raw product samples monthly, ensuring 100% GMP compliance and documentation accuracy.
- Reviewed 150+ batch manufacturing records quarterly, identifying and resolving 10+ documentation deviations across production records.
- Coordinated deviation investigations and CAPA documentation, reducing repeat quality issues by 22% through corrective action support.
- Maintained laboratory QC logs with 99% data integrity accuracy, ensuring traceability and regulatory readiness for inspections.
Certifications
IATA – Shipping of Category A & B Infectious Substances
Myo Clinic Laboratories
Verified International Academic Qualifications (WES)
World Education Services
Health Canada Division 5 Certification
Academy of Applied Pharmaceutical Sciences
TCPS2 – Ethical Conduct for Research Involving Humans
Tri-Council Policy Statement
CTMS Platform Training
Academy of Applied Pharmaceutical Sciences
ICH GCP R3 Training
Syneos Health
Projects
Review Paper – Pulsatile Drug Delivery Systems (JETIR)
JETIR (Journal Publication)
Author & Research Analyst
Skills Used
- Scientific Literature Review, Drug Delivery Systems, Regulatory Analysis, Pharmaceutical Research
Key Roles
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Authored peer-reviewed research paper analyzing multiple pulsatile drug delivery technologies.
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Reviewed over 40 scientific studies evaluating formulation strategies and drug release mechanisms.
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Synthesized regulatory considerations influencing modified release pharmaceutical approvals.
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Evaluated formulation approaches and drug release kinetics for therapeutic effectiveness.
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Documented research findings aligned with scientific publishing and regulatory standards.
Formulation & Evaluation of Pulsatile Drug Delivery System for Nocturnal Asthma
Academic Research Project
Research Lead & Formulation Developer
Skills Used
- Pharmaceutical Formulation, Drug Release Kinetics, Stability Testing, Laboratory Research
Key Roles
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Developed prototype formulations targeting delayed drug release for nocturnal asthma treatment.
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Conducted dissolution and kinetic analysis optimizing lag time for drug release.
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Performed compatibility and stability testing under controlled laboratory conditions.
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Documented laboratory results following GMP oriented research documentation standards.
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Evaluated formulation performance through multiple experimental research studies.
