Ankita Patil
Pune
Summary
Experienced (3 Years) Pharmacovigilance Associate with a proven track record of excellence in triage, ICSR case processing, and clinical trial case processing. Seeking a challenging role to contribute my skills and knowledge in ensuring drug safety and compliance.
Overview
6
6
years of professional experience
Work History
Pharmacovigilance Scientist 1
Tata Consultancy Services
Pune
12.2022 - Current
- Efficiently managed the triage process, promptly reviewing categorizing adverse event reports
- Conducted thorough ICSR case processing, ensuring accurate documentation, and timely submissions to regulatory authorities.
- Proficiently handled clinical trial case processing, collaborating with cross-functional teams to meet project timelines
- Implemented quality control measures, resulting in a significant reduction in errors and improved compliance
- Accountable for handling ICSR files received via data exchange systems, disposition of valid Items into case processing tool from receipt intake tool for further processing in ARIS,LSMV.
- Handling invalid items in IRT appropriately through reference to SOP's, relevant training and the ARIS user manual
- Identifying possible SUSAR and informing to hierarchy and case processers through mailers to maintain timeline of expedited safety package (ESP) reporting and drug timeline if any
- Developing and maintaining knowledge of the appropriate disease biology areas and associated client product's knowledge
Saftey Science Analyst
Labcorp Drug Devlopment
Pune
01.2021 - 01.2022
Executive 1 ( Quality Assurance)
Synapse Labs Pvt, Ltd.
Pune
05.2019 - 12.2020
Education
B. Pharmacy -
Shree Santkrupa College of Pharmacy
Karad06-2016
Skills
- Adverse event reporting
- Medical terminology
- Medical Records review
- ArisG
- Ag exchange
- LSMV
- Argus
- Microsoft Office
- Communication
- Teamwork
- Problem Solving
- Time Management
- Leadership
- Organizational Skills
- Critical Thinking
- GXP Scope
- ICH/GCP guidelines
- US CFR 31480
- US CFR 31232
- MedDRA
- WHO_DRUG dictionaries
Accomplishments
1. Star of the Month Award, August 2024
2. Best ICSR Processor Award in August 2024
Languages
- English, Fluent
- Hindi, Fluent
- Marathi, Fluent
Strengths
1.Self Motivation.
2.Leading and Ready to take up challenging jobs with diversified nature.
3.Adapting to changing circumstances
4.Self-Confidence
5.Good communication skills
Timeline
Pharmacovigilance Scientist 1
Tata Consultancy Services
12.2022 - Current
Saftey Science Analyst
Labcorp Drug Devlopment
01.2021 - 01.2022
Executive 1 ( Quality Assurance)
Synapse Labs Pvt, Ltd.
05.2019 - 12.2020
B. Pharmacy -
Shree Santkrupa College of Pharmacy
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