Ayesha Rubina

Leads medical safety for clinical trials and post-marketing studies across oncology, rheumatology, neurology and vaccines; performs medical review of AEs/ADRs, authors aggregate reports (DSUR, PADER, PBRER), supports audits/DSMBs and manages PV budgets and escalation to EU QPPV.

Performed medical review and clarification of AEs/ADRs, represented safety findings to clients, reviewed and signed off safety and medical monitoring plans, and authored/ reviewed aggregate safety reports (DSUR, PBRER, PADER).

Authored and QC'd regulatory and safety documents including Clinical Overviews, RMPs, IB toxicology sections, patient safety narratives and PBRERs to support label and IB updates.

Taught pharmacology to MBBS and MD students, participated in institution pharmacovigilance committee, contributed to clinical study protocols and hospital formulary development.

Provided inpatient and emergency care across internal medicine, obstetrics & gynecology and minor surgical procedures, managing emergencies and assisting major surgeries.

Worked in internal medicine, emergency, intensive care and neurology units; handled emergency cases and minor surgeries and assisted in major operations.

Activities and societies: Teaching MBBS students, training postgraduates, participation in pharmacovigilance committee, protocol development

Completed MD in Pharmacology with involvement in teaching, protocol development, and participation in clinical and preclinical study activities.

Completed a postgraduate diploma program focused on clinical research principles and practices.

Activities and societies: Clinical rotations, emergency care, minor surgical procedures, patient care

Completed MBBS program at JJM Medical College affiliated to Kuvempu University; clinical training and rotations across medicine, surgery, emergency, and obstetrics/gynecology.