Ambika Nagarawat

Detail-oriented Pharmacovigilance professional with over one year of hands-on pharmaceutical analytical and quality experience, certified in Pharmacovigilance with Basics of Regulatory Affairs (BCRi, Bengaluru). Skilled in adverse event reporting, Individual Case Safety Report (ICSR) case identification, data entry, and processing, MedDRA coding fundamentals, signal detection concepts, and global PV regulations (ICH E2A-E2F, CDSCO, EMA, FDA). Additional certification in Regulatory Affairs strengthens understanding of regulatory submissions and dossier compliance.

Brings strong GMP/GDP documentation discipline, analytical rigor, and attention to detail from Quality Control operations - directly transferable to case processing, safety database management, and follow-up on serious and non-serious cases as per client guidelines and global regulatory requirements. Comfortable working in rotational shifts and open to relocation.

Quality Control Executive - Analytical Validation - Graviti Pharmaceuticals Pvt. Ltd. - Hyderabad

(2024-11 - 2025-11)

• Handled deviations, OOS/OOT investigations, CAPA, and change control - analytical rigor directly transferable to case causality assessment and signal review in pharmacovigilance
• Maintained analytical worksheets, validation records, and logbooks with strict adherence to GMP and Good Documentation Practices, ensuring audit-ready, error-free case files
• Executed HPLC-based cleaning validation studies, ensuring equipment cleanliness and regulatory compliance
• Supported Analytical Method Validation (AMV) activities under ICH guidelines, maintaining complete and accurate validation records
• Performed routine and non-routine analysis of raw materials, in-process samples, and finished products against approved specifications, demonstrating precision and process-driven discipline suited to ICSR data entry and follow-up

QC Analyst Training - Rainbow Pharma Training Lab - Hyderabad

• Performed core QC tests - Average Weight, Weight Variation, Friability, Disintegration (DT), and Karl Fischer (Water Content) per USP guidelines
• Trained in Dissolution testing, Assay determination, and Uniformity of Dosage Units (UOD) by HPLC

M.Sc. - Biochemistry - Gulbarga University, Kalaburagi - Main Campus (2021 - 2023)

B.Sc. - Chemistry, Biology & Zoology - S.B. College of Science, Gulbarga University, Kalaburagi (2018 - 2021)