Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
4
4
years of professional experience
Work History
Safety Science Coordinator II
LABCORP (Covance)
03.2021 - 04.2023
Executed drug safety data management processes, including case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation, and submission to regulatory authorities
Recognized for client excellence in managing Tylenol legal cases with 100% HA Compliance, timely turnaround to stakeholders for review of CIOMS and consistent quality
Implemented consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
Operational Specialist & Drug Safety Associate
IQVIA-BIOTECH
11.2018 - 02.2021
Ensured accurate and consistent coding of all events for serious and non-serious cases entered in Argus with use of MedDRA
Maintained PV expertise, and understanding of international safety regulations and guidelines
Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
Boosted efficiency in handling individual case safety reports through meticulous tracking and organization.
Education
Bachelor’s of Pharmacy (B Pharm) -
Mumbai University
Mumbai, India
07.2018
Regulatory Affairs And Quality Operations (Co-op) -
Fanshawe College
London, Ontario
08.2024
Skills
4 years of work experience in leading Clinical Research Organization (CRO) companies
Attention to detail and accuracy resulted in highest quality on all deliverables, with 95% on time delivery rate
Developed problem solving & analytical skills by identifying opportunities to improve efficiency in process and procedures
Coordinated with multiple teams and stakeholders to ensure timely and accurate completion of deliverables while maintaining sense of urgency during challenging situations
Skilled in using Microsoft Excel/Word and PowerPoint
Timeline
Safety Science Coordinator II
LABCORP (Covance)
03.2021 - 04.2023
Operational Specialist & Drug Safety Associate
IQVIA-BIOTECH
11.2018 - 02.2021
Bachelor’s of Pharmacy (B Pharm) -
Mumbai University
Regulatory Affairs And Quality Operations (Co-op) -