Bizineche Diana

Expertise in maintaining Trial Master File (TMF) quality and completeness in alignment with ICH-GCP guidelines. Managed critical documentation for new molecule development and international clinical trials. Key contributor to regulatory readiness, ensuring documentation integrity for audits. Proficient in Veeva Vault eTMF system, quality control, and cross-functional team collaboration. This experience provides essential insight into the clinical drug lifecycle and safety documentation requirements.

5 years of experience as a licensed Pharmacist, serving as the frontline contact for patient safety.Key responsibilities included Adverse Drug Reaction signal detection and triage, escalating suspected cases to management per internal PV procedures.Provided expert patient counseling on side effects, drug interactions, and proper medication administration.Managed dispensing of controlled substances (Tab II/III) and performed medication reconciliation,ensuring high standards of care and regulatory compliance.

Developed expertise in pharmacovigilance regulations (national & EU) and safety reporting requirements.

Deepened understanding of global regulatory frameworks and submission processes.