Puneet Kaur

Accountable for the review, interpretation, analysis, and summarization of aggregate safety data from all sources, including medical review and authoring of periodic benefit-risk evaluation reports. Summarized relevant new safety information impacting the benefit-risk profile of medicinal products and prepared reference safety information documents like core data sheets.

Performed medical review of individual case safety reports, literature publications, and abstracts for potential signal detection, assessing cases for seriousness and Important Medical Events. Maintained awareness of global regulatory reporting obligations and organized workload to ensure compliance with regulatory timelines.

Involved in the medical review of individual case safety reports and literature, contributing to signal detection activities. Ensured adherence to global regulatory reporting obligations and managed workload to meet compliance timelines.

Attended to neurosurgery emergencies and handled critical patients, particularly in intensive care and high dependency units. Undertook preoperative and postoperative care of patients and managed the neurosurgery outpatient department, including diagnosis and prescription writing.

Involved in admission and discharge daily inpatient notes, regular checkups, and emergency case management. Tracked time management history and examinations, contributing to diagnosis and prescription writing for patients.

Focused on regulatory strategy for product development and lifecycle management, including coursework in food and drug administration’s pharmaceutical regulation and regulatory compliance. Completed projects such as creating a lifecycle plan for a medical device.

Undertook comprehensive coursework in surgery, medicine, and various clinical and non-clinical subjects. Gained foundational knowledge essential for medical practice.