Pankaj Kalaskar

Background

About Pankaj Kalaskar

I am an experienced Safety Data Analyst with a focus on pharmacovigilance, committed to safeguarding patient health by ensuring the safety and efficacy of pharmaceutical products. My expertise lies in analyzing adverse event data, identifying and supporting regulatory compliance to minimize risks associated with medicinal products. I am proficient in using various pharmacovigilance tools and databases (such as Argus, ArisG, IDREAM and MedDRA) and applying data visualization techniques to track, analyze and report adverse events. My experience spans working closely with cross-functional teams, including quality assurance team to ensure comprehensive safety assessments. Key competencies include: Individual case safety report (ICSR) triage, case processing, quality review and regulatory reporting to regulatory authorities (e.g. USFDA, EMA, MHRA, etc.) Proficiency in multiple pharmacovigilance databases (Argus and ArisG), Work Instructions and Job Aid preparation, Test scripts writing and its execution, user acceptance testing (UAT), regression testing and performance testing of pharmacovigilance tool (IDREAM). I am passionate about leveraging data to contribute to the safety and well-being of patients worldwide, and I am always looking to collaborate with like-minded professionals in the field of pharmacovigilance and drug safety.