Ramya Yalamanchi
Hamden,CT
Summary
Enthusiastic, dedicated Pharmacovigilance expert with Four years of experience in Clinical and Pharmacovigilance, including Case processing which includes booking, data entry, MedDRA Coding, and Narrative Writing.
Medical Evaluation of ICSR, Aggregate Reports, Signal Detection, Risk Management, Benefit-Risk.
Analysis, Risk Evaluation, Mitigation Strategies, and medical assessment/ evaluation as well.
Eager to contribute to team success through hard work, attention to detail, and excellent organizational skills,
Trained & Certified with a Clear understanding of Pharmacovigilance and Clinical trials.
Motivated to learn, grow, and excel in the field.
Overview
5
5
years of professional experience
Work History
Graduate Assistant
Sacred Heart University
Fairfield, CT
03.2023 - 03.2024
- · Reviewed study protocols and played a key role in planning and implementing data management aspects of clinical research projects.
- · Collaborated with Study Coordinators, Project management, and development team for regulatory monitors to review and analyze data, ensuring participant safety and protocol compliance.
- · Performed mixed-method research techniques including statistical data analysis, semi-structured in-depth interviewing, and participatory design sessions.
- · Responsible for research recruitment, documenting deliverables, data collection, management, analysis, and scientific writing
Drug Safety Associate
Aurobindo Pharma Unit III
08.2019 - 08.2023
- · Served as safety medical expert to evaluate Individual case safety reports (ICSR) for all company products either marketed or in clinical development.
- · Performed regular medical case reviews for all ICSRs reported from any source including clinical trials, literature, post-marketing studies, and post-marketing spontaneous adverse event reports ensuring complete and timely review aligning with internal and external reporting timelines. Reported adverse drug events to comply with regulatory policies and procedures.
- · Triaged, and assessed reported adverse events (AE) and serious adverse events (SAE) and utilized clinical and global introspection methodologies aligned with global regulations to provide company causality assessment.
- · Actively involved in reviewing all Adverse events (AEs) and Serious Adverse events (SAEs) accurately reported and captured patient clinical status and confirmed that events were correctly coded with MedDRA and confirmed seriousness criteria.
- · Efficiently Assessed AE and SAE expectedness for each event per Reference Safety Information (RSI) and ensure correct, consistent interpretation and application to ICSRs
- · Provided the medical input and review needed for the creation of aggregate reports (PBRER, DSUR, PADER) as needed to support compounds in clinical development or post-approval.
- · Ensure compliance with all applicable drug safety regulations and guidelines, including FDA and EMA requirements, to maintain a high standard of safety reporting and pharmacovigilance practices.
Education
Master of Science - Healthcare Informatics
Sacred Heart University
Fairfield, CT03.2024
Bachelor of Science - Bachelor of Dental Surgery
Kamineni Institute of Dental Sciences
Nalgonda, Telangana, India03.2019
Skills
- Case processing on Argus & safety easy
- Medical Assessment
- MedDRA Coding
- Narrative writing
- Excellent Medical assessment
- Aggregate reporting, Signal detection, Risk management,
- PV audits and documentation Risk management and Mitigation Strategies in the United States
- Knowledge of safety databases (Argus & Safety Easy), FDA Industry Guidelines, ICH Guidelines
- Knowledge of pre-and post-marketing Pharmacovigilance
- Excellent knowledge of Microsoft Office: PowerPoint, Word, Excel Good written and oral communication skills
- Excellent Working knowledge and familiarity with medical terminology
- Ability to work collaboratively as part of a team Self-motivation and ability to drive results independently
- Excellent organizational skills
- Customer care standards
- FDA and ICH Guidelines
- Detail-oriented
Timeline
Graduate Assistant
Sacred Heart University
03.2023 - 03.2024
Drug Safety Associate
Aurobindo Pharma Unit III
08.2019 - 08.2023
Master of Science - Healthcare Informatics
Sacred Heart University
Bachelor of Science - Bachelor of Dental Surgery
Kamineni Institute of Dental Sciences
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