DR. Apoorva Rachana Kulkarni

Regulatory operations specialist at Alpine Immune Sciences

Dr. Apoorva Rachana Kulkarni has a diverse range of work experience in the pharmaceutical industry. DR. Apoorva Rachana started their career at Ramaiah Memorial Hospital in 2018, where they worked as a Doctor of Pharmacy. During this time, they gained experience in critical prescription review, ward-round participation, pharmacovigilance, and patient medication history interviews and counseling.

In 2019, Dr. Kulkarni joined Novo Nordisk as a Drug Safety Associate. Here, they handled pharmacovigilance safety databases for adverse events from clinical trials, following internal and external guidelines. DR. Apoorva Rachana worked with the Argus 8.1.2 system and ensured compliance with safety regulations.

In 2021, Dr. Kulkarni moved to Freyr Solutions as a Regulatory Associate. DR. Apoorva Rachana'sresponsibilities included planning, preparation, tracking, coordination, revision, and publishing of labeling process documentation. DR. Apoorva Rachana collaborated with subject matter experts in cross-functional teams and managed CAPA, CMC, and continuous improvement CRFs using various tools such as Veeva Vault, SharePoint, Microsoft Office, and Adobe.

Currently, Dr. Kulkarni is working at Alpine Immune Sciences, Inc. as a Regulatory Operations Specialist. DR. Apoorva Rachana began their role in July 2022 and is involved in regulatory operations within the company.

Throughout their career, they have demonstrated expertise in regulatory affairs, drug safety, and pharmacy practice, making their a valuable asset to any pharmaceutical organization.

Dr. Apoorva Rachana Kulkarni completed their Doctor of Pharmacy (PharmD) degree from M.S. Ramaiah University of Applied Sciences, Bangalore, between 2013 and 2019. DR. Apoorva Rachana'sfield of study was pharmacy.

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Timeline

  • Regulatory operations specialist

    July, 2022 - present