Jyothi Pulapalli
Leander,TX
Summary
Pharm.D graduate with 2 years of experience as a Drug Safety Associate and a strong background in pharmacovigilance and drug safety operations. Proficient in adverse event (AE) case processing, MedDRA coding, and compliance with international regulatory guidelines. Demonstrated expertise in workflow management, cross-functional collaboration, and safety data evaluation. Highly detail-oriented with strong problem-solving and analytical skills, ensuring timely and accurate delivery of safety-related reports.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Preschool Teacher
Stepping Stone School
Leander, USA
05.2024 - 12.2024
- Designed and delivered age-appropriate lesson plans that encouraged curiosity and exploration in young learners
- Managed classroom behavior and ensured a safe, inclusive learning environment
- Strengthened interpersonal and organizational skills through collaboration with staff and parents
Preschool Teacher
Jupiter House Preschool
Cedar Park, USA
07.2023 - 10.2023
- Facilitated a nurturing and engaging learning environment for children, supporting their cognitive and social development
- Planned and implemented creative educational activities tailored to individual learning styles and needs
- Communicated effectively with parents and staff to ensure the well-being and progress of students
Drug Safety Associate
Bioclinica
Mysore, India
01.2021 - 12.2022
- Collected, reviewed, and analyzed adverse event (AE) reports from healthcare professionals, patients, and clinical trials
- Performed accurate data entry of AE information into safety databases following regulatory and company guidelines
- Assessed the seriousness and expectedness of reported adverse events
- Ensured compliance with global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines
- Supported timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities
- Collaborated with medical reviewers to ensure consistency in case assessments
- Assisted in identifying potential safety signals and escalating critical cases for further review
- Maintained comprehensive and accurate case documentation in line with company policies
- Conducted quality control checks to ensure data accuracy and completeness in reports
- Assisted in identifying trends and patterns related to adverse events for signal detection and risk management activities
- Coordinated with cross-functional teams, including regulatory affairs, clinical operations, and medical affairs, to support drug safety operations
- Participated in team meetings to discuss process improvements and resolve case-related queries
- Completed ongoing pharmacovigilance training to stay updated on regulatory changes
- Supported audit and inspection readiness by maintaining compliance with standard operating procedures (SOPs)
Intern
Kamineni Institute of Medical Sciences (KIMS)
Narketpally, India
01.2018 - 01.2019
- Conducted clinical rounds in General Medicine, Pulmonology, OBGYN, EMERGENCY MEDICINE, Psychiatry and Orthopedics, gaining experience in patient care and therapy management
- Documented adverse drug reactions (ADRs) and assisted in preparing reports for clinical use
- Performed medication reviews to ensure drug safety and efficacy in diverse patient populations
- Provided drug information and recommendations to healthcare teams based on clinical evidence
- Observed and implemented pharmacovigilance practices, including ADR identification and reporting
Education
Doctor of Pharmacy -
Jawaharlal Nehru Technological University (JNTU)
Hyderabad, India01.2019
Intern -
Kamineni Institute of Medical Sciences (KIMS)
Narketpally, Telangana, India01.2019
Skills
- Pharmacovigilance Knowledge
- Medical and Scientific Knowledge
- Regulatory Compliance
- Data Analysis and Interpretation
- Safety Databases
- Attention to Detail
- Critical Thinking
- Communication Skills
- Time Management
- Team Collaboration
- Adaptability
Certification
- Good Clinical Practice for ICH-GCP: Full certificate course.
- Certificate Course in Pharmacovigilance.
- Pharmaceutical industry Pharmacovigilance and Drug safety.
- Professional certificate in Regulatory Compliance.
- The Simplest guide to Clinical Trials data Analysis with SAS.
- Certified by Telangana Pharmacy council as a Registered Pharmacist.
Projects
Evaluation of Drug Interactions in a Tertiary Care Hospital, Investigated and documented clinically significant drug-drug interactions from patient records., Categorized interactions by severity and developed recommendations to mitigate risks., Gained hands-on experience in analyzing patient data and identifying safety concerns., Presented findings to medical teams to enhance drug safety awareness.
Timeline
Preschool Teacher
Stepping Stone School
05.2024 - 12.2024
Preschool Teacher
Jupiter House Preschool
07.2023 - 10.2023
Drug Safety Associate
Bioclinica
01.2021 - 12.2022
Intern
Kamineni Institute of Medical Sciences (KIMS)
01.2018 - 01.2019
- Good Clinical Practice for ICH-GCP: Full certificate course.
- Certificate Course in Pharmacovigilance.
- Pharmaceutical industry Pharmacovigilance and Drug safety.
- Professional certificate in Regulatory Compliance.
- The Simplest guide to Clinical Trials data Analysis with SAS.
- Certified by Telangana Pharmacy council as a Registered Pharmacist.
Doctor of Pharmacy -
Jawaharlal Nehru Technological University (JNTU)
Intern -
Kamineni Institute of Medical Sciences (KIMS)
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