Namrata Tapkir

Motivated and detail-oriented B. Pharmacy fresher with knowledge of Clinical research, Pharmacovigilance and ICH-GCP guidelines, ADR reporting, ICSR Case Processing and clinical trial documentation through academic projects and internship experience. Skilled in data handling, medical writing, and maintaining accurate records. Eager to contribute to drug safety monitoring and regulatory compliance.

INTERN - KEM HOSPITAL PUNE - Pune

(2025-06-01 - 2025-07-31)

Clinical Research in Ethics committee

• Maintained and reviewed documentation as per ICH-GCP and regulatory guidelines
• Ensured compliance with SOPs and Good Documentation Practices (GDP)
• Assisted in preparation and verification of regulatory documents
• Maintained accurate records and proper filing systems
• Coordinated with teams for documentation accuracy and compliance
• Gained exposure to GMP, pharmaceutical workflow, and production-related documentation practices

Bachelor of Pharmacy - Pharmacy - Savitribai Phule Pune University (2022 - 2026)

Higher Secondary Certificate - Maharashtra State Board (2022 - 2022)

Secondary School Certificate - Maharashtra State Board (2020 - 2020)