Sakshi Kolhe

Dedicated Doctor of Pharmacy (Pharm.D) and certified Pharmacovigilance professional with hands-on expertise in end-to-end ICSR processing using the Clinevo Safety Database. Highly skilled in medical narrative writing, MedDRA coding, case triage, and causality assessment with a strong command of ICH-GCP and GVP guidelines. Proven track record of conducting rigorous drug safety surveillance and Adverse Event (AE) reporting during a 1-year clinical internship and a published observational study.

Passionate about ensuring regulatory compliance and high-quality safety data management within global pharmacovigilance operations.

Clinical Pharmacist Intern at Ruby Hall Clinic, Hinjewadi (2025-12 – 2026-05)

• Managed end-to-end Adverse Drug Reaction (ADR) reporting and documentation, performing initial case triage, validity checks, and data entry into institutional safety logs.
• Authored comprehensive medical narratives from clinical case studies in the general medicine department, standardizing medical record abstraction for accurate safety surveillance.
• Executed rigorous medication reviews and prescription audits, collaborating with physicians to handle product complaints and mitigate potential adverse events.

Clinical Pharmacist Intern at Lokmanya Hospitals (2025-06 – 2025-11)

• Extracted and validated critical clinical data from patient medical records across Orthopaedics, ICU, and General Surgery to support comprehensive safety case documentation.
• Conducted in-depth causality assessments for suspected adverse events using WHO-UMC and Naranjo scales, supporting accurate clinical safety evaluations.
• Performed extensive Drug-Drug Interaction (DDI) assessments and provided evidence-based drug information services to optimize patient medication regimens and enhance drug safety.

PG Diploma in Clinical Research and Pharmacovigilance in Clinical Research and Pharmacovigilance – Professional Certification (2026-03 – 2026-07)

Doctor of Pharmacy (Pharm.D) in Pharmacy – Savitribai Phule Pune University (2020 – 2026)

Higher Secondary Certificate (HSC) – St. Paul College, Nagpur (2017 – 2019)