Jhansi

Drug Safety Specialist Pv Scientist @Otsuka Pharmaceutical Companies (U.S.)

US

Pharmacovigilance & Drug Safety Specialist Conducted quality reviews of clinical trial and post-marketing cases, providing timely feedback to case processors. Managed triage of incoming cases to optimize workflow and prioritization. Assisted in the preparation of Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs). Performed duplicate checks and initiated individual case safety reports (ICSRs) in the ARISg safety database. Processed ICSRs, including data entry and validation, ensuring compliance with regulatory requirements. Managed vendor operations, including quality checks of vendor cases and participation in vendor meetings. Authored detailed and accurate clinical case narratives, ensuring chronological consistency of medical information. Assessed case validity, seriousness, expectedness, and causality using the WHO-UMC system. Assigned medical codes to adverse events, medical history, and concomitant medications in compliance with regulatory standards. Conducted medical and drug terminology reviews as per project-specific coding conventions and regulatory guidelines. Verified case data for accuracy, consistency, and compliance with process requirements. Utilized MedDRA Coder Browser (MCB) for accurate coding of adverse events, medical history, and laboratory investigations. Identified and processed SUSAR cases from clinical trials and managed serious/non-serious post-marketing cases. Evaluated cases for medical review and company reporting. Maintained a strong understanding of the adverse event safety profile of assigned products. Monitored and tracked Product Quality Complaints. Conducted literature case review and coding, including analysis of medical journals, poster presentations, and full articles. Generated follow-up letters to obtain missing case information and clarifications.

Kakatiya University (University College of Pharmaceutical Sciences)

Doctor of Pharmacy - PharmD