Venkata Kishore Kumar Darisi

About Venkata Kishore Kumar Darisi

Throughout my career, I have been driven by a simple purpose: advancing patient safety…

Experience

1. Serm Associate Scientific Director

   GSK

   Jun 2023 — Present · Bengaluru, IN

   Act as a Safety Lead and develop safety strategy for assigned products and maintain oversight of the execution of the safety strategy.• Provides high-level scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the post-marketing setting.• Lead and drive safety evaluation activities for complex products, ensure that appropriate safety objectives and risk minimization strategies are included in clinical development and/or the post-marketing setting, and show confidence, credibility, and influence at all levels of the organization.• Supports effective decision-making for ongoing safety activities.• Drive and ensure that adverse events and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements, and drive implementation of risk management initiatives.• Presents the safety strategy for products at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, external consultants, and other companies such as licensing partners.• Provide strategic inputs and data for safety sections for maintenance of labeling for assigned products and support licensing activities. Presents labeling recommendations for complex issues to the GSK Global Labelling Committee or Global Safety Board.• Acts as a Subject Matter Expert in the team on scientific aspects and processes related to SERM activities.• Provides functional training, mentoring, and coaching for staff in the team, as necessary.• Lead and represent SERM and support during regulatory authority inspections, internal audits, and process improvement activities.• Assist SERM Line Managers/Project Managers in the management of safety projects as a functional expert and provide recommendations for continuous improvement.

Education

• Harvard Medical School

  HMX Fundamentals Pharmacology, Pharmacology

  2019 — 2019

• Massachusetts College of Pharmacy and Health Sciences

  Master’s Degree, Regulatory Affairs and Health Policy

  2015 — 2017

• Indian School of Business

  General Management Programme, Business Administration and Management, General

  2018 — 2019

• Acharya Nagarjuna University

  B. Pharmacy, Pharma

  2005 — 2008

• Vagdevi College of Pharmacy and Research Centre

  Diploma in Pharmacy, Pharmacy

  2003 — 2005

Skills

• Medical Writing
• Clinical Development
• Neuroscience
• Regulatory Affairs
• Life Sciences
• Pharmacovigilance
• Pharmaceutical Industry
• Sop
• Drug Safety
• Regulatory Submissions
• Clinical Research
• Pharmaceutics
• CRO
• Ich-Gcp
• Pharmaceutical Research
• Validation
• Therapeutic Areas
• Clinical Trials
• Pharmacology
• Gcp
• Pharmacokinetics
• Oncology