Arun Kumar Kuna
Patient Safety, PV Soutions / Clinical Trials Safety Operations, Regulatory Submissions
- Role
- Assistant Manager at Fortrea
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Arun Kumar Kuna
Overseeing the case handling, triage and processing of clinical trial and spontaneous postmarketing events. Assisting in the management and analysis of safety data with a particular emphasis on support to clinical development teams, and helps define the pharmacovigilance needs of clinical development teams, advising and providing guidance to clinical development teams on safety matters. Take part in the review and input in investigator brochure content, expert reports, and pooled study data. Review and evaluate individual adverse events/reactions. Perform initial assessments of cases, review and modify case narrative. Participation in the reconciliation between the Clinical Trial Database and the pharmacovigilance database to ensure quick and complete data validation. Assist with trial end activities in preparation for clinical study report. Provide input in the review of the safety aspects of study protocols and reports. Case approval for non-serious, non-reportable cases after data entry is complete. Case unblinding at trial termination. Specialties: Drug Safety and Epidemiology Pre-Clinical and Clinical Pharmacology (Cardiovascular research) Clinical Pharmacokinetics and Pharmacodynamics
Experience
Assistant Manager
Jul 2023 — Present · Bengaluru, IN
Patient Safety Solutions, Clinical Safety Operations, Submissions Management, Lead activities.
Education
Al-Ameen College of Pharmacy/Rajiv Gandhi University of Health Sciences
M. Pharm (Pharmacology)
2008 — 2010
Government College of Pharmacy/Rajiv Gandhi University of Health Sciences
B. Pharm
2003 — 2007
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