Kishore Kumar Email and Phone Number
As a Drug Safety Associate at Qinecsa Solutions, I process various ICSR reports from different sources, ensuring accuracy, completeness and compliance with regulatory requirements. I have proven expertise in MedDRA coding, drug coding, seriousness, causality, and labeling assessments, as well as in generating concise and well-written case narratives following ICH, GVP, FDA and EMA guidelines. With a PharmD degree from JNTU, Anantapur, I have a strong background in Pharmacy and clinical research. I have worked for two top organizations Qinecsa and IQVIA, where I gained valuable experience and skills in MedDRA coding, literature screening and review, ICSR case processing and team management. Comprehensive knowledge on aggregate reporting (DSUR, PSUR, PBRER and PADER).I am passionate about Pharmacovigilance, dedicated to contribute my knowledge and skills for drug safety and efficacy. Committed to organizational growth, success and embracing new challenges/initiatives with a laser focus on high standards of quality and responsibility.
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Business Process LeadTata Consultancy Services Sep 2024 - PresentKarnataka, India -
Drug Safety AssociateQinecsa Solutions Jan 2021 - Aug 2024Mysore, Karnataka, India>> Processed serious and non-serious ICSR reports from Spontaneous cases, regulatory authoritycases, literature cases, clinical trials, Partner cases, product quality complaints and Pregnancyreports.>> Proactively took leading initiatives with passion as a pseudo peer reviewer for projectmanagement and provided guidance activities or training materials for new teammates>> Recommended for digital quality tracking systems for project efficiency which resulted intoPVTrace development.>> Coding using MedDRA conventions and coding medications using WHODrug dictionary.>> Learned about CAPA documentation and root cause analysis for leadership skill development.>> Performed high quality assessments for seriousness, causality, expectedness/labeling, andprioritized cases accordingly for regulatory submissions. -
Drug Safety AssociateIqvia India Apr 2018 - May 2019Bengaluru, Karnataka, India>> As a case processor analyzed full case information on the Argus safety database andsupporting source documents to ensure accuracy and completeness.>> Prioritized ICSR’s based on seriousness, causality, and expectedness/labeling according toregulatory requirements.>> Performed adverse event coding, medical history, underlying medical conditions and otherlaboratory data using global clinically validated MedDRA dictionary.>> Coded medications appropriately using global WHODD and CDD.>> Generated concise, accurate, chronological, and well-written case narratives in ArisG.>> Ensured for self-quality checks before routing the case to next workflow steps and doublecheck for validations.>> Ensured expedited reporting’s processed swiftly in timelines.
Kishore Kumar Education Details
Frequently Asked Questions about Kishore Kumar
What company does Kishore Kumar work for?
Kishore Kumar works for Tata Consultancy Services
What is Kishore Kumar's role at the current company?
Kishore Kumar's current role is Business Process Lead | Drug Safety | Pharmacovigilance.
What schools did Kishore Kumar attend?
Kishore Kumar attended Jawaharlal Nehru Technological University, Anantapur.
Who are Kishore Kumar's colleagues?
Kishore Kumar's colleagues are Vamshika Narala, Sneha Boda, Padmabhushan Ganacharya, Vishnu Vardhaan, Maheknaaz Aslam, Santhosh Polu, Jasvinder Arora.
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Kishore Kumar
Senior Hr Executive @ Resulticks | Certified Performance Management ProfessionalChennai -
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