Kalpana Donapati

Detail-oriented Pharmacy graduate seeking an entry-level role in Pharmacovigilance where I can apply my knowledge of ICSR processing, Medical Dictionary for Regulatory Activities coding, and drug safety surveillance to ensure regulatory compliance and patient safety.

Pharmacovigilance-focused professional with strong academic knowledge of ICSR lifecycle management, adverse event reporting, MedDRA coding, and safety database workflows. Familiar with ICH-GCP and GVP guidelines, case triage, narrative writing, and follow-up processes. Skilled in maintaining data accuracy, regulatory compliance, and quality review standards. Eager to contribute to drug safety and risk management activities.

Title: Analytical Method Development and Validation of Vadadustat (RP-HPLC)

Objective:

Develop and validate an RP-HPLC method for accurate drug quantification as per ICH guidelines.

Contribution:

• Performed method development, optimization, and validation (accuracy, precision, linearity, stability)
• Handled sample preparation, data analysis, and ensured regulatory-compliant documentation

Outcome:

• Achieved accurate, reproducible analytical method with validated results

Key Learnings:

• Strong data accuracy, documentation, and quality control skills
• Exposure to ICH guidelines and regulatory compliance
• Attention to detail relevant to pharmacovigilance (ICSR processing, safety data handling)

• ICH-GCP Guideline Certification — NIDA Clinical Trials Network (July 2025)
• Pharmacovigilance Concepts: AE, ADR, SAE, SUSAR (Academic Knowledge)
• ICSR Processing & MedDRA Coding (Coursework Knowledge)