Anushka Bagchi
Drug Safety Associate
Mumbai
Summary
A passionate and detail-driven Pharmacovigilance and Medical Coding professional, I bring 3+ years of rich experience in ensuring patient safety and regulatory compliance in top-tier pharmaceutical projects. I thrive in fast-paced MNC environments where accuracy, ethics, and collaboration are vital. My mission is to be a catalyst in healthcare innovation by delivering safety, precision, and strategic data management. I am now seeking to join a global life sciences team where I can make an immediate and lasting impact. Offering solid foundation in scientific principles and keen interest in pharmacovigilance, eager to learn and grow in supportive environment. Brings understanding of regulatory requirements and data management techniques. Ready to use and develop analytical skills and regulatory understanding in Drug safety analyst role.
Overview
4
4
years of professional experience
2
2
Certifications
1
1
Language
Work History
Pharmacovigilance Associate
Accenture India Pvt. Ltd.
Mumbai
01.2024 - Current
- Analyze adverse event reports to ensure accuracy and compliance with regulatory standards.
- I worked on Argus, as well as Veeva.
- Increased department accuracy through rigorous quality control checks on ICSR entries prior to submission, minimizing the potential for errors or discrepancies.
- Played an instrumental role in successful audits by maintaining organized files and providing detailed explanations regarding pharmacovigilance activities when necessary.
- Contributed to risk management strategies by identifying trends and patterns in adverse event reporting, leading to proactive measures for patient safety.
- Reduced workload backlog by effectively prioritizing high-priority cases based on severity level and regulatory deadlines during peak periods of volume influx.
- Expedited case processing times by creating customized templates for common adverse event scenarios, allowing for faster completion without sacrificing detail or quality.
- Strengthened interdepartmental communication by collaborating closely with clinical teams, ensuring timely exchange of critical information related to drug safety.
- Supported global pharmacovigilance activities by liaising with international colleagues on common case processing practices, fostering a unified approach to drug safety monitoring.
- Improved data quality for regulatory submissions by conducting thorough case assessments in compliance with FDA guidelines.
- Read scientific literature and bibliographic sources.
- Oversaw adverse events case reporting and conducted follow-up.
- Authored and managed regular safety update reports.
- Assessed and distributed pharmaceutical product adverse event documents.
Drug Safety Associate
Cognizant Technology Solutions
Kolkata
10.2022 - 01.2024
- Evaluated biomedical literature for adverse events, ensuring data quality.
- Structured safety reports and handled regulatory submissions with accuracy.
- Improved patient safety by accurately reviewing and processing adverse event reports.
- Assisted in the development and implementation of training materials, contributing to the ongoing education of fellow Drug Safety Associates.
- Incorporated varying medical philosophies and idiosyncrasies of health care delivery to generate global reports.
- Collaborated with cross-functional teams to develop risk mitigation strategies for drug products.
- Maintained up-to-date knowledge on relevant regulations and guidelines, ensuring compliance in all aspects of work as a Drug Safety Associate.
- Enhanced drug safety monitoring with thorough assessment of case data and identification of potential risks.
- Supported the preparation of periodic safety update reports, showcasing attention to detail and commitment to accurate reporting.
- Compared adverse event source documents against safety database screens for transcription and medical accuracy.
Pharmaceutical Industrial Trainee
Golden Cross Pharma
Sikkim
04.2022 - 05.2022
- Gained experience in Quality Control, Production, and Packaging processes in OSD.
- Worked closely with industrial professionals to expand upon acquired training with practical knowledge.
- Managed documentation related to standard operating procedures, ensuring accurate record keeping and easy access for employees.
- Repaired, cleaned and maintained equipment.
- Conducted thorough quality inspections of finished products, ensuring adherence to company standards and customer satisfaction.
- Completed projects on time and within budget by effectively coordinating resources, schedules, and communication among team members.
- Participated in continuous improvement initiatives that led to enhanced operational performance and cost reductions.
- Assisted with implementation of new safety instructions and equipment protocols.
Education
Bachelor in Pharmaceutical Technology - Pharmaceutical Sciences
Adamas University
Kolkata, India 04.2001 -
Higher Secondary Education - PCMB
WBCHSE
West Bengal, India04-2016
High School Diploma -
Maharani Kasiswari Girls' High School
Berhampore 04.2001 -
Skills
Medical Coding
Drug safety expertise
Continuous learning mindset
Pharmacovigilance regulations
Scientific literature review
Adverse event reporting
Medical terminology
Risk management strategies
Case processing
Cross-functional coordination
Certification
- Drug Development | UC San Diego (Coursera, 2022)
Why Should You Hire Me?
- I bring a unique blend of precision, passion, and professionalism to every task. My extensive experience in pharmacovigilance and medical coding, combined with a proven track record at top-tier firms like Accenture and Cognizant, ensures I can deliver regulatory excellence and drive patient safety. I am highly adaptable, tech-savvy, and fluent in multiple languages, which positions me to work seamlessly in global, cross-functional teams.
- What sets me apart:
- - Strong foundation in life sciences and data science with certified courses from Johns Hopkins and UC San Diego
- - Proactive communicator and collaborator who thrives under pressure
- - Committed to continuous learning and delivering impact from day one
Reading
I enjoy reading fiction as it helps improve my creativity, focus, and understanding of different perspectives. It also strengthens my communication skills and provides a balanced way to relax and stay mentally engaged.
Timeline
Pharmacovigilance Associate
Accenture India Pvt. Ltd.
01.2024 - Current
Drug Safety Associate
Cognizant Technology Solutions
10.2022 - 01.2024
Pharmaceutical Industrial Trainee
Golden Cross Pharma
04.2022 - 05.2022
Bachelor in Pharmaceutical Technology - Pharmaceutical Sciences
Adamas University
04.2001 -
High School Diploma -
Maharani Kasiswari Girls' High School
04.2001 -
Higher Secondary Education - PCMB
WBCHSE