Aafiya Khan

I am a highly motivated Drug Safety Professional with over eight years of experience in Pharmacovigilance, specializing in ICSR processing from sources including spontaneous reports, clinical trials, literature, licensing partners, and post-marketing surveillance.

I have hands-on expertise with the ARGUS database and a strong understanding of Good Pharmacovigilance Practices (GVP) and ICH-GCP guidelines, and I have worked extensively on SAE processing, AE data management, coding, and narrative writing.

As a Safety Aggregate Report Specialist and Operations Specialist, I contributed to literature review and signal detection, supported aggregate reporting (PSUR, PBRER, DSUR, RMP) and ensured timely, compliant distribution of safety reports to regulatory stakeholders.

During a recent career break to pursue an M. Pharmacy (Quality Assurance), I deepened my knowledge in quality systems (CAPA, RCA, Change Control), regulatory compliance (GMP, GDP, GLP), and audit readiness; I am eager to apply this combined operational and quality expertise to advance drug safety and regulatory compliance.