SHWETA MISHRA
Sultanpur,Uttar Pradesh
Summary
Healthcare Consultant with 15+ years of experience transitioning into Pharmacovigilance and Drug Safety Consulting. Skilled in safety data analysis, SQL, and safety system implementation (Argus/Vault concepts). Strong understanding of AE case processing, ICSR lifecycle, and regulatory compliance (ICH, FDA, EMA). Proven ability to gather requirements, design solutions, and deliver as an individual contributor in consulting environment
Overview
15
15
years of professional experience
1
1
Certification
Work History
Digital Healthcare Consultant
Maahi Dental Care
Sultanpur
01.2020 - Current
- Designed AE tracking and safety data frameworks
- Developed SQL-based datasets and reports for risk analysis
- Led requirement gathering for safety system integration
- Ensured data integrity and compliance (CSV principles)
- Impact: +30% improvement in reporting efficiency
Healthcare Business Analyst
Aastha Dental Hospital
Sultanpur
01.2016 - 12.2019
- Implemented structured safety data capture systems
- Built analytical reports using SQL/Excel logic
- Supported workflows aligned with case processing lifecycle
- Impact: +20% efficiency in care delivery
Resident Dental Consultant
Axiss Dental and Ravina Clinic
New Delhi
07.2011 - 11.2015
Clinical Workflow & Documentation
Education
Bachelor of Dental Surgery -
Manipal College of Dental Sciences
Mangalore08-2010
Skills
- Pharmacovigilance: AE Processing, ICSR, Aggregate Reports (PSUR/DSUR)
- Safety Systems: Vault Safety (concept), Argus, RxLogix (exposure)
- SQL & Analytics: Complex queries, safety data analysis, reporting
- Consulting: Requirement Gathering, Solution Design, Stakeholder Management
- Compliance: CSV, ICH E2E, FDA, EMA
Certification
- Diploma in Hospital Administration, Medvarsity, Apollo Hospital, Hyderabad
- Project Management Foundations, Linkedin Learning
- Becoming a Business Analyst, Linkedin Learning
- Digital LSH and LSH Tech Certificates
Languages
- English
- Hindi
Registration
Registered with Uttar Pradesh Dental Council
Key Projects
Vault Safety Implementation (Simulated)
- Designed end-to-end AE case workflows & data models (E2B aligned)
- Created solution architecture for safety system implementation
Argus Safety & SQL Analytics
- Simulated ICSR lifecycle workflows
- Wrote complex SQL queries for safety data analysis
Aggregate Reporting Automation
- Built framework for PSUR/DSUR reporting
- Reduced manual effort via data integration & automation
Pharmacovigilance Data Analytics
- Designed safety data models and reporting dashboards
Languages
English
Proficient (C2)
C2
Hindi
Native
Native
ADDITIONAL INFORMATION
- Strong communication & stakeholder collaboration
- Individual contributor with consulting mindset
- Willing to travel (25%)
- Exposure to SaaS/Cloud-based safety systems
Timeline
Digital Healthcare Consultant
Maahi Dental Care
01.2020 - Current
Healthcare Business Analyst
Aastha Dental Hospital
01.2016 - 12.2019
Resident Dental Consultant
Axiss Dental and Ravina Clinic
07.2011 - 11.2015
Bachelor of Dental Surgery -
Manipal College of Dental Sciences