Open to opportunities

Kanchan Desale

@kanchandesale

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Pharmacovigilance professional ensuring high-quality safety reporting and compliance.

India

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What I'm looking for

I am seeking a pharmacovigilance role where I can advance patient safety through accurate ICSR processing, regulatory submissions, signal detection, and continuous process improvement within a collaborative, compliance-focused team.

I am a results-driven Pharmacovigilance Associate with 2.5 years of hands-on experience in clinical and post-marketing ICSR processing, regulatory submissions, and signal detection. I consistently delivered 98%+ quality compliance while ensuring timely global safety reporting.

I have practical expertise in Argus, ARISg, Veeva Vault, MedDRA and WHO-DD coding, and a strong working knowledge of FDA, EMA, ICH-GVP and ICH-GCP requirements. At TCS and IQVIA I managed end-to-end case processing, performed seriousness and expectedness assessments, conducted literature searches for signal detection, and supported inspection readiness and audits.

I seek to apply my attention to detail and process-optimization mindset to strengthen pharmacovigilance operations and improve patient safety, drawing on accomplishments such as reducing processing turnaround time by 20% and mentoring new team members for faster onboarding.

Experience

Work history, roles, and key accomplishments

Pharmacovigilance Specialist

Tata Consultancy Services

Jan 2022 - Jun 2023 (1 year 5 months)

Managed end-to-end collection, triage, processing, and reporting of AEs/ADRs across clinical trials and post-marketing programs, ensuring 100% documentation compliance and timely regulatory submissions per FDA/EMA/ICH-GVP.

Argus MedDRA Safety Reporting Regulatory Submissions Quality Control

Pharmacovigilance Associate

IQVIA

Mar 2021 - Nov 2021 (8 months)

Processed and reviewed ICSRs with high adherence to SOPs and global safety guidelines, performed MedDRA/WHO-DD coding, literature searches for signal detection, and template customization to reduce processing time.

MedDRA WHO DD Quality Control Triage

Clinical Research Coordinator

ReMedi Clinical Research Services

Nov 2020 - Feb 2021 (3 months)

Assisted regulatory submissions, patient recruitment, informed consent documentation, and study monitoring while maintaining trial master files and ensuring ICH-GCP inspection readiness.

Regulatory Submissions Patient Recruitment Monitoring ICH GCP Data Collection Trial Master File Documentation

Education

Degrees, certifications, and relevant coursework

MGV's College of Pharmacy

Master of Pharmacy, Pharmacology

2018 - 2020

Grade: 9.0/10

Activities and societies: Research project: Assessment of Hepatoprotective Activity of Methanolic Extract of Ipomoea obscura (Dec 2019 – Mar 2020)

Master of Pharmacy in Pharmacology completed with a GPA of 9.0/10, focusing on pharmacology coursework and a research project on hepatoprotective activity.

MGV's College of Pharmacy

Bachelor of Pharmacy, Pharmacy

2014 - 2018

Grade: 71%

Bachelor of Pharmacy completed with a final percentage of 71%, covering pharmaceutical sciences and practical training relevant to clinical research and pharmacovigilance.