Kanchan Desale
Pharmacovigilance Specialist
Dubai,Dubai
Summary
Dynamic Pharmacovigilance Associate with over 2.5 years of experience in pharmacovigilance, driving excellence in adverse event report processing and regulatory compliance. Expertise in electronic case triaging and a thorough understanding of ICH guidelines and global regulatory requirements ensure the highest standards of safety and data integrity. Holding 98% quality of task in every month with strong analytical skills, attention to detail, and ability to manage high workloads efficiently while ensuring regulatory adherence. Adapt at prioritizing tasks to meet deadlines and uphold patient safety standards in a fast-paced environment.
Overview
3
3
years of professional experience
6
6
years of post-secondary education
1
1
Language
Work History
Pharmacovigilance Associate
TCS
Pune
01.2022 - 07.2023
- Expertly managed 200+ adverse event report processing in every month, ensuring compliance with FDA guidelines and timely, accurate submissions to regulatory authorities
- Proficient in electronic case triaging, prioritizing case timelines with precision and extensive training
- Deep understanding of ICH guidelines, GCP, and global regulatory requirements for case submissions
- Coordinated case follow-ups, reviewing targeted questionnaires and narratives for completeness.
- Assisted in quality review of safety database entries and collaborated with management for audits.
- Collaborated with medical writers to develop concise and accurate safety narratives for inclusion in regulatory submissions, ensuring key information was effectively communicated.
- Ensured regulatory compliance by maintaining accurate documentation and audit readiness.
Pharmacovigilance Associate
IQVIA
Mumbai
03.2021 - 11.2021
- Expertly managed the logging and triage of Individual Case Safety Reports (ICSR) into the safety database
- Ensured high-quality processing and review of ICSR, maintaining strict adherence to SOPS and safety information guidelines
- Proficient in safety database operations, with fluency in MedDRA and WHO-DD coding systems
- Executed meticulous data entry of adverse drug events, achieving complete and error-free case records
- Communication of identified safety issues to manager
- Monitor PV data on country Health Authority websites and check for changes in local/regional regulatory environment, updating PV System accordingly
- Analyzed case seriousness and ensured timely submission of reports in compliance with regulatory requirements.
- Expedited case processing times by creating customized templates for common adverse event scenarios, allowing for faster completion without sacrificing detail or quality.
Intern: Clinical Research Coordinator
Remedi clinical research services
Nashik
10.2020 - 02.2021
- Assisted in the preparation and submission of regulatory documents to FDA.
- Monitored clinical study progress, ensuring adherence to GCP guidelines.
- Developed study protocols aligning with regulatory and ethical standards.
- Maintained compliance with protocols covering patient care and clinical trial operations.
Education
M.D. - Pharmacology
MGV's College of Pharmacy
Nashik 05.2018 - 07.2020
J.D. - Pharmacy
MGV's College of Pharmacy
Nashik 05.2014 - 09.2018
Skills
- Pharmacovigilance Databases: Argus, ARISg, Oracle Safety Suite
- Regulatory & Compliance: ICH-GCP, FDA, EMA, MHRA regulations
- Medical Coding: MedDRA, WHO-DD
- Microsoft Office: Excel, Word, PowerPoint
- Core skills: ICSR Case Processing & Triage, Adverse Event Reporting & Analysis, Data Analysis & Regulatory Submissions, Risk Management & Signal Detection, Team Collaboration & Process Improvement
Personal Information
- Nationality: Indian
- Driving License: No
- Visa Status: Family visa
Timeline
Pharmacovigilance Associate
TCS
01.2022 - 07.2023
Pharmacovigilance Associate
IQVIA
03.2021 - 11.2021
Intern: Clinical Research Coordinator
Remedi clinical research services
10.2020 - 02.2021
M.D. - Pharmacology
MGV's College of Pharmacy
05.2018 - 07.2020
J.D. - Pharmacy
MGV's College of Pharmacy
05.2014 - 09.2018
Similar Profiles
Abhilasha ChandelAbhilasha Chandel
Ui/UX Designer at TCSUi/UX Designer at TCS
Nora BounabatNora Bounabat
Senior Talent Acquisition Specialist SAP at TCSSenior Talent Acquisition Specialist SAP at TCS
Renuha RVRenuha RV
Engineer at TCSEngineer at TCS