KDKanchan Desale
@kanchandesale
Pharmacovigilance professional ensuring high-quality safety reporting and compliance.
IndiaWhat I'm looking for
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
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.
IQProcessed 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.
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.
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.
Availability
Location
IndiaAuthorized to work in
Job categories
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