Oracle Argus Safety
Prathamesh Kakde
Pharmacovigilance Associate | Drug Safety Professional
Malkapur
Summary
Developed comprehensive understanding of drug safety and regulatory compliance in fast-paced pharmaceutical environment. Demonstrates expertise in data analysis and adverse event reporting, with focus on patient safety. Seeking to transition into new field where these transferable skills can drive impactful results.
Overview
1
1
year of professional experience
2
2
Certifications
Work History
Pharmacovigilance Associate – Case Processing
Tata Consultancy Services (TCS)
03.2025 - Current
- Case Management & Triage: Executed end-to-end ICSR (Individual Case Safety Report) data entry and triage within Argus Safety, ensuring the high-fidelity capture of adverse events, medicinal products, and patient demographics.
- Workflow Execution: Orchestrated comprehensive case processing, including trigger identification, MedDRA/WHODrug coding support, and rigorous seriousness assessments, in strict accordance with global pharmacovigilance guidelines.
- Regulatory Submission Readiness: Validated the submission readiness of safety cases by crafting and reviewing clinical narratives, and ensuring all outputs aligned with global SOPs and international regulatory requirements (e.g., FDA, EMA, MHRA).
- Reduced workload backlog by effectively prioritizing high-priority cases based on severity level and regulatory deadlines during peak periods of volume influx.
- Enhanced patient safety by meticulously reviewing and analyzing adverse event reports.
Education
Bachelor of Pharmacy - Pharmaceutical Sciences
Sir Dr MS Gosavi Collage Of Pharmaceutical Education
Nashik 04.2001 -
Skills
- CSR Case Processing & Safety Data Triage
- Adverse Event & Drug Coding Support
- Case Quality Review & Regulatory Compliance
- Oracle Argus Safety & eCOA Systems
- Veeva Vault
- MedDRA (Basic Knowledge)
- Safety Narrative Review & Documentation
- Knowledge of ICH-GCP Guidelines
- Microsoft Excel & Data Management
- Attention to Detail & Time Management
Software
Veeva Vault
Certification
Advancing Transparency and Regulatory Science Activities on Risk Evaluation and Mitigation Strategy (REMS) – U.S. FDA
Interests
Learning about new drugs, disease management, and clinical research trends
Timeline
Pharmacovigilance Associate – Case Processing
Tata Consultancy Services (TCS)
03.2025 - Current
Bachelor of Pharmacy - Pharmaceutical Sciences
Sir Dr MS Gosavi Collage Of Pharmaceutical Education
04.2001 -