SAYALI DUDE
PUNE
Summary
Results-driven Pharmacovigilance Scientist with a comprehensive background in pharmaceutical safety and regulatory compliance. Recent MBA graduate in Operations, eager to apply a strategic and analytical approach to pharmaceutical operations management. Seeking opportunities to leverage dual expertise in pharmacovigilance and operations on an MBA basis, contributing to organizational growth and excellence.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Patient Safety Specialist
TATA CONSULTANCY SERVICES
PUNE
07.2020 - Current
- Adverse event (AE) coding by MedDRA browser and drug coding by WHODD browser, hands on experience on Safety Database CARA, Sapphire and ARISg-AG Exchange.
- Work allocation and prioritization of cases in order to smooth workflow of cases within the regulatory reporting timelines to avoid late reporting of cases, adhering to productivity, timeline compliance and quality of cases.
- Assessing the validity and priority of the case and case creation (book-in) safety database and identifying duplicate/invalid ICSRs and triage of incoming case to determine the seriousness for prioritization of daily workflow.
- Participated in quality assurance activities such as chart reviews, incident investigations, risk assessments.
- Provided excellent service and attention to customers when face-to-face or through phone conversations.
- Planned and completed group projects, working smoothly with others.
- Trained new employees in proper safety procedures to minimize accidents with proper behaviors.
- Wrote technical reports, data entry and queries into various safety and health databases.
Education
MBA - Operations Management
Dr. D. Y. PATIL VIDYAPEETH
PUNE09-2023
POST GRADUATE DIPLOMA - REGULATORY AFFAIRS
MIT WORLD PEACE UNIVERSITY
PUNE06-2020
GRATUATION - B. PHARMACY
SAVITRIBAI PHULE UNIVERSITY
PUNE05-2019
HIGHER SECONDARY CERTIFICATE -
MAHARASHTRA STATE BOARD
YEOLA06-2014
SECONDARY SCHOOL CERTIFICATE -
MAHARASHTRA STATE BOARD
PUNE03-2012
Skills
- Quality Improvement
- Healthcare Regulations
- Incident Investigation
- Medical Terminology Knowledge
- Critical Thinking
- Program Development
- Root Cause Analysis
- Risk Assessment
- Quality Assurance
- Supervision and Leadership
- Organizational Skills
- Microsoft Office
- Forecasting Planning
- Operational Improvements
Certification
- Rubicon (Barkley's) Workshop included soft skill development, Communication Skills Development.
- Attended Two Days National Level Seminar on Pharmaceutical Quality Assurance, Its importance and Its Needs.
- Completed Pharmacovigilance and Clinical Research Diploma.
Languages
English
First Language
Marathi
Beginner
A1
Hindi
Beginner
A1
Timeline
Patient Safety Specialist
TATA CONSULTANCY SERVICES
07.2020 - Current
MBA - Operations Management
Dr. D. Y. PATIL VIDYAPEETH
POST GRADUATE DIPLOMA - REGULATORY AFFAIRS
MIT WORLD PEACE UNIVERSITY
GRATUATION - B. PHARMACY
SAVITRIBAI PHULE UNIVERSITY
HIGHER SECONDARY CERTIFICATE -
MAHARASHTRA STATE BOARD
SECONDARY SCHOOL CERTIFICATE -
MAHARASHTRA STATE BOARD
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