Savita Kulkarni

I’m a detail-oriented and collaborative Drug Safety Associate with 4 years of experience in pharmacovigilance and safety case processing, supporting both clinical trial and post-marketing programs. I focus on accurate case management and compliant reporting across serious and non-serious adverse events.

In my current role, I process and manage ICSRs from post-marketing reports, literature, partner/litigation submissions, and regulatory sources. I handle quality control tasks like duplicate checks, single-case unblinding, discrepancy resolution, and follow-up coordination to maintain case integrity and timely expedited submissions.

I’m experienced in adverse event coding and classification using MedDRA and WHO-Drug, including seriousness and causality assessment and expectedness vs. labeling. I prepare chronological case narratives covering patient history, concomitant medications, outcomes, and relevant follow-ups, while ensuring SOP compliance and prompt reporting per ICH, FDA, EMA, and CIOMS guidance.

Beyond case processing, I support safety evaluations through literature screening and structured search strategies. I search PubMed, EMBASE, MEDLINE, and local journals using Boolean operators and filters, extract drug safety details, and assess whether events meet ICSR generation criteria.