VIJAYA AISHWARYA DUNE
Missouri,USA
Summary
Results-driven professional with a strong background in pharmacovigilance, clinical safety management, and regulatory compliance. Over three years of experience in drug safety aggregate reporting, signal management, and adverse event assessment, ensuring adherence to global regulatory standards. Additionally, five years of leadership experience in business and operational management, excelling in team leadership, resource allocation, and process optimization. Currently pursuing a master’s in project management, enhancing expertise in clinical operations, workflow efficiency, and risk management. Adept at driving quality improvements, streamlining safety reporting processes, and implementing strategic solutions in healthcare and life sciences.
Overview
9
9
years of professional experience
Work History
Business & Operational Manager
Jawed Habib
, India
03.2019 - 08.2024
- Spearheaded strategic business operations from inception, including site selection, investment planning, and regulatory compliance
- Led financial planning by overseeing tax filings, supplier invoices, and ensuring regulatory adherence
- Optimized operational efficiency by streamlining vendor partnerships, securing long-term contracts, and automating workflow processes
- Developed branding and marketing initiatives, utilizing digital platforms and social media to boost visibility and client engagement
- Boosted revenue growth by implementing innovative promotional strategies, customer loyalty programs, and partnership collaborations
- Managed and trained high-performing teams, ensuring excellence in customer service and operational execution
- Enhanced customer experience by refining service delivery, monitoring feedback, and optimizing client interactions
Drug Safety Aggregate Reporting Specialist
IQVIA
, India
12.2015 - 03.2019
- Conducted high-precision pharmacovigilance reporting, ensuring compliance with global regulatory requirements
- Performed rigorous quality checks (QC) on serious adverse event cases and signal management reports, minimizing compliance risks
- Collaborated with cross-functional teams, including regulatory affairs, clinical operations, and medical safety experts, to improve report accuracy
- Led literature searches and article testing, utilizing specialized databases to identify safety signals and generate comprehensive assessments
- Ensured case validity and consistency, overseeing data entry, event coding, and adverse event classification with a focus on precision and adherence to SOPs
- Provided mentorship and training for new hires, strengthening team competency in safety reporting and pharmacovigilance operations
Education
Master's - Project Management
Missouri State University
Missouri, USA05.2025
Graduate certification - Supply Chain Management
05.2025
Registered Pharmacist License -
Pharmacy Council of India
India01.2016
Bachelor of Pharmacy (B. Pharm) -
Maharajah's College of Pharmacy
India01.2015
Skills
- MS Office Suite (Excel, Word, PowerPoint)
- Search Engines & Databases: PubMed, Medline, EMC, NCBI
- ENDNOTE
- Right Find
- Tableau
- Gantt Chart
- Adobe Creative Suite
- Project Libre
- Microsoft Project
- Pharmacovigilance & Safety reporting
- Signal Detection & Management
- ICSR Processing & Quality Check
- Aggregate Report Assessment
- SOP development & Regulatory Adherence
- Literature Review & Data Interpretation
- Risk & Quality Management
- Adverse Event Coding & Case Validity
- Financial & Tax Management
- Process Optimization & Workflow Enhancement & Management
- Team Leadership & Cross-functional Collaboration
- Recruitment & Training
- Client & Market Analysis
- Branding
- Marketing & Promotional Strategies
Websites
Key Achievements And Activities
- IQVIA – Best Performer Award & Applause Awards for Quality Excellence
- Jawed Habib – Outstanding Leadership Award & Business Growth Award
- Internship, Hands-on exposure to laboratory and quality testing techniques, Mahidhara Chemicals Pvt. Ltd., Vishakhapatnam, Andhra Pradesh
- Research & Publications, Co-authored a paper on Natural Medicinal Products, Sri Venkateshwara College
- Presentations, Poster Presentation on Bio-Adhesive Drug Delivery System, Koringa College of Pharmacy
Timeline
Business & Operational Manager
Jawed Habib
03.2019 - 08.2024
Drug Safety Aggregate Reporting Specialist
IQVIA
12.2015 - 03.2019
Master's - Project Management
Missouri State University
Graduate certification - Supply Chain Management
Registered Pharmacist License -
Pharmacy Council of India
Bachelor of Pharmacy (B. Pharm) -
Maharajah's College of Pharmacy
Similar Profiles
RAGA PRAVALLIKA PENNETIRAGA PRAVALLIKA PENNETI
Receptionist & Beautician at Jawed Habib QcityReceptionist & Beautician at Jawed Habib Qcity
Suresh DhanalakotaSuresh Dhanalakota
Proprietor at Jawed Habib ChandanagarProprietor at Jawed Habib Chandanagar
Jessica SinghJessica Singh
Intern at Jawed habibIntern at Jawed habib
Teja KanneboinaTeja Kanneboina
Intern at IEEE-SB PITIntern at IEEE-SB PIT
Keerthi KiranKeerthi Kiran
Operations & Strategy Associate at AramarkOperations & Strategy Associate at Aramark