SWETHA S SHETTY
Mangalore
Summary
Dynamic Analyst with a proven track record at IQVIA, excelling in adverse event reporting and project management. Recognized for outstanding contributions with two IQVIA Impact Awards, I effectively foster client relations and ensure pharmacovigilance compliance, demonstrating strong problem-solving abilities and meticulous attention to detail in high-stakes environments.
Overview
5
5
years of professional experience
Work History
Analyst
IQVIA
Bangalore
05.2024 - Current
- Led AE and product quality complaint handling for both brand impact and custom market research studies.
- Managed full project lifecycle from planning to delivery; identified and reported adverse events to clients
- Acted as the primary client contact, provided regular updates, and supported client audits by addressing queries and gaps.
- Owned AE detection, reporting, and reconciliation; sent finalized reports to end clients.
- Conducted internal quality assurance and audit activities, adhering to corporate standards.
- Quality Control and CAPA Management.
- Trained new joiners and established team competency as a subject matter expert in AE processes.
- Managed high-profile client projects for Pfizer, Amgen, Novartis, Takeda, AstraZeneca, and Gilead.
Senior Clinical Research Associate
Ascentrik Research Pvt. Ltd.
Pune
06.2023 - 06.2023
- Due to health difficulties, I had to leave the organization during training period itself.
Senior Global Data Associate
IQVIA
Bangalore
10.2020 - 10.2022
- Directed adverse event (AE) and product quality complaints, overseeing both brand impact and custom market research studies to ensure timely reporting of adverse events.
- Maintain full compliance with IQVIA and client pharmacovigilance SOPs.
- Support internal PV training, reconciliation activities, and ensure alignment with GVP and client-specific requirements.
- Served as the primary client liaison, delivering structured project updates, and proactively addressing audit queries to uphold transparency and trust.
- Conducted internal quality assurance and audit activities, adhering to corporate standards.
- · Earned two IQVIA Impact Awards (Bronze & Silver) for outstanding work contributions.
Education
M. Pharm - Pharmacology
N.G.S.M. Institute of Pharmaceutical Sciences
Mangalore, Karnataka07-2020
B. Pharm - Mangalore
N.G.S.M. Institute of Pharmaceutical Sciences
Mangalore06-2018
Advance Program in Clinical Research & Management - Clinical Trial Operations, Clinical Data Management, Pharmacovigilance, and Medical Writing
Clini India
Skills
- Adverse event reporting
- Project management
- Data reconciliation
- Client relations
- Pharmacovigilance compliance
- Regulatory understanding
- Team training
- Effective communication
- Problem solving
- Attention to detail
- OE Coding
- MS Project
- Pharmacology
Languages
- English
- Hindi
- Kannada
- Tulu
Timeline
Analyst
IQVIA
05.2024 - Current
Senior Clinical Research Associate
Ascentrik Research Pvt. Ltd.
06.2023 - 06.2023
Senior Global Data Associate
IQVIA
10.2020 - 10.2022
M. Pharm - Pharmacology
N.G.S.M. Institute of Pharmaceutical Sciences
B. Pharm - Mangalore
N.G.S.M. Institute of Pharmaceutical Sciences
Advance Program in Clinical Research & Management - Clinical Trial Operations, Clinical Data Management, Pharmacovigilance, and Medical Writing
Clini India