Nagesh Rao Venkobarao

• Design and lead an inclusive training framework in collaboration with clients, leadership, subject matter
experts (SMEs), and the Learning Team to address project-specific training needs.
• Responsible for assessing training requirements, ensuring process compliance with quality standards, and
supporting Root Cause Analysis (RCA) and the implementation of Corrective and Preventive Actions (CAPA).
• Facilitate project-specific training sessions as needed and actively support the training function during audits
and regulatory inspections, serving as a representative of the training organization.
• Develop training materials and design comprehensive training programs; coordinate expert-led sessions on
industry and regulatory developments; and create hiring questionnaires, SOPs, and other supporting
documentation as needed.

• Manage cases from the reporting workflow, assessing reportability in accordance with quality
documentation and regulatory requirements.
• Generate, review, and archive CIOMS forms; execute subsequent distribution steps as per reporting
guidelines.
• Ensure all communications and acknowledgments are accurately documented and archived within the client
safety database, including updating distribution records.
• Maintain trackers with ICSR submission and acknowledgment details to support compliance tracking.

• Collaborates with the Functional Management Team to develop and update project-specific training
processes and curricula, ensuring alignment with operational needs and compliance standards.
• Oversees the end-to-end training process for the project, including onboarding for new joiners, refresher
sessions, and ongoing learning initiatives.
• Coordinate with administration team to request access provisioning or revocation for project team
members, ensuring proper assignment, completion, and documentation of required trainings.

• Performed quality assurance reviews of Clinical Trial, Post-marketing and Literature case reports to ensure
strict compliance with regulatory requirements.
• Conducted trend analysis of errors, identified root causes, and led refresher training sessions to enhance
team performance and reduce recurring issues.
• Documented and analysed process deviations, driving implementation of corrective actions to improve
overall process efficiency and effectiveness.
• Proactively identify, support, and implement continuous improvement initiatives to enhance process
efficiency and quality.

• Prioritized and accurately entered serious and non-serious cases into the global safety database, ensuring adherence to SLA and regulatory deadlines.
• Consistently applied MedDRA coding to medical history, laboratory data, drugs, and adverse events to maintain data standardization.
• Authored comprehensive safety narratives for serious, non-serious, literature, and regulatory cases.
• Maintain accurate archiving of all case-related emails, source documents, and pertinent information within the client safety database.
• Processed serious and non-serious cases via E2B import with high accuracy and compliance.
• Managed the triage unit, performing case assessments for expectedness, causality, and expedited reporting requirements.

• Delivered lectures and workshops to undergraduate and graduate students, enhancing learning
engagement.
• Mentored students on projects and internships, providing academic and professional support.
• Developed and implemented an updated pharmacotherapeutics curriculum to improve student outcomes.
• Collaborated with faculty to create course materials and align learning objectives with institutional
standards.
• Authored and published research in peer-reviewed journals, significantly contributing to the advancement
of pharmacotherapeutics.

• Provided expert drug information and patient counselling to support optimal clinical outcomes.
• Reviewed prescriptions for accuracy, drug interactions, and appropriateness based on clinical guidelines.
• Collaborated with healthcare teams to optimize pharmacotherapy and ensure patient safety.
• Counselled patients on medication usage, side effects, adherence, and lifestyle modifications.
• Managed drug information services, responding to inquiries from physicians, nurses, and patients.
• Participated in clinical rounds to provide pharmacological expertise in treatment decisions.