Hiral Gosai

MediPharmSolutions

09.2023 - Current

Determined the reportability of cases to local and international regulatory authorities and ensured timely submissions
Reviewed spontaneous reports and clinical trial cases for marketed and investigational compounds to determine regulatory reporting responsibilities
Processed serious adverse event information per sponsor's standard operating procedures and submitted ICSRs to regulatory authorities within compliance timelines
Performed medical coding using MedDRA and WHO DD
Monitored electronic mailboxes for timely acceptance of AE reports and performed data entry into databases
Generated queries to obtain missing case information for complete assessment
Conducted quality reviews for AEs, SAEs, and SUSARs
Demonstrated strong organizational and teamwork skills to meet regulatory requirements and ensure high-quality outputs
Utilized knowledge of specific work practices, SOPs, and regulations to oversee vendor activities and ensure task execution
Managed case triage, data entry, narrative writing, and quality review
Coded adverse event terminology and other medical information in the safety database as per coding policies and standards
Reconciled safety event queries with the data management team promptly.
Followed all company policies and procedures to deliver quality work.