V KISHORE KUMAR DARISI
Summary
Global Patient Safety leader with over 16 years of experience in Pharmacovigilance, Safety Evaluation & Risk Management (SERM), Medical Safety, Regulatory Science, and Global Safety Operations within leading multinational pharmaceutical organizations. Proven track record of leading cross-functional global teams, driving benefit-risk assessments, signal detection, safety surveillance, regulatory submissions, and labeling strategies across the product lifecycle in therapeutic areas including oncology, neuroscience, ophthalmology, infectious diseases, and advanced therapy medicinal products (ATMPs).
Experienced in building high-performing teams, leading organizational transformation, and delivering strategic initiatives involving digital innovation, process automation, inspection readiness, vendor governance, and operational excellence while ensuring compliance with ICH, FDA, EMA, PMDA, and global pharmacovigilance regulations. Recognized for scientific leadership, stakeholder collaboration, and the ability to translate complex safety data into informed regulatory and business decisions that enhance patient safety and organizational performance.
Overview
15
15
years of professional experience
1
1
Certification
Work History
SERM Associate Scientific Director
GSK
Bangalore
06.2023 - Current
- Provide strategic scientific leadership for multiple clinical development and lifecycle assets, serving as the Safety Evaluation & Risk Management (SERM) Lead and driving benefit-risk assessments, safety surveillance, and risk management strategies throughout the product lifecycle.
- Lead and chair cross-functional Safety Surveillance Team (SST) meetings, driving evidence-based safety decisions and presenting benefit-risk evaluations and recommendations to Global Safety Boards, Safety Review Teams (SRTs), and Medicines Development Boards (MDBs).
- Direct signal detection, signal evaluation, and safety assessments by integrating evidence from clinical trials, post-marketing surveillance, scientific literature, real world evidence, and global health authority databases to support proactive patient safety decisions.
- Provide strategic oversight and scientific leadership for aggregate safety reports, including PSURs, PBRERs, DSURs, and safety sections of NDA, BLA, and MAA submissions, ensuring high-quality scientific content and global regulatory compliance.
- Represent Global Patient Safety in cross-functional development teams, partnering with Clinical Development, Regulatory Affairs, Clinical Pharmacology, Epidemiology, Toxicology, Biostatistics, and Medical Affairs to develop and implement integrated safety strategies.
- Represent GSK during regulatory authority interactions, including FDA Pre-IND Type B and Type C meetings, providing scientific input on clinical safety strategies and supporting regulatory decision-making.
- Support global health authority inspections and regulatory audits by providing scientific expertise, responding to safety-related queries, and contributing to inspection readiness and CAPA implementation.
- Lead global labeling strategy by providing scientific recommendations for safety labeling updates, benefit-risk evaluations, and risk minimisation measures, supporting governance boards in maintaining compliant and patient-centric product information.
- Review and provide scientific input into key clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, INDs, CTAs, and due diligence assessments for business development opportunities.
- Provide scientific oversight for post-marketing safety surveillance activities, including PASS, Non-Interventional Studies (NIS), additional Pharmacovigilance Activities (aPVA), and additional Risk Minimisation Measures (aRMMs) for priority assets.
- Lead, coach, and develop a team of four safety professionals through performance management, scientific mentoring, and capability development while fostering a collaborative, high-performing, and patient-focused culture.
- Served as the Global Patient Safety Subject Matter Expert (SME) for the DAWN (Document Automation with Natural Language Generation) Generative AI program, partnering with Digital, Clinical Development, Medical Writing, and Regulatory teams to define business requirements, evaluate AI-generated outputs, support user acceptance testing, and enable automation of Clinical Study Reports (CSRs), Clinical Summaries, safety submission documents, and clinical trial narratives, advancing AI-driven transformation of regulatory document authoring.
Lead-Safety Evaluation & Risk Management, PVO, SLM
Aspen Pharmacare
Hyderabad
03.2021 - 06.2023
- Led global Pharmacovigilance Operations, Safety Evaluation & Risk Management (SERM), Medical Writing, Regulatory Writing, Safety Labeling, and Signal Management functions, providing strategic and operational leadership across the product lifecycle.
- Managed a Global Patient Safety organization comprising 65 professionals across India, with direct leadership of seven Team Leads responsible for SERM, Signal Management, Safety Labeling, Regulatory Writing, and Medical Writing, driving organizational capability, succession planning, and high-performance team development.
- Successfully transitioned global Pharmacovigilance and Medical Writing operations from Ireland to India, establishing a high-performing Global Business Services (GBS) delivery model that delivered approximately 40% operational cost savings while maintaining quality, compliance, and business continuity.
- Served as Deputy to the Head of Pharmacovigilance and QPPV, supporting strategic decision-making, pharmacovigilance governance, regulatory compliance, organizational planning, and executive leadership of the Global Patient Safety function.
- Directed preparation, scientific review, and approval of aggregate safety reports and regulatory documents, including PSURs, PBRERs, DSURs, RMPs, Investigator’s Brochures, CTD modules, Clinical Study Reports, and other global regulatory submissions in accordance with ICH, EMA, FDA, MHRA, and other international regulatory requirements.
- Led global signal detection, benefit-risk evaluation, safety governance, and risk management activities, ensuring timely identification, assessment, communication, and mitigation of emerging safety issues across global product portfolios.
- Directed inspection readiness activities and successfully led multiple global regulatory authority inspections and audits, including MHRA, SAHPRA, BfArM, Health Canada, HPRA, and internal quality audits, ensuring sustained regulatory compliance and timely implementation of corrective and preventive actions.
- Managed functional budgets, workforce planning, resource allocation, and vendor governance, including vendor selection, contract negotiations, performance management, and service level oversight to ensure efficient, high-quality global pharmacovigilance delivery.
- Partnered with senior leaders across Regulatory Affairs, Clinical Development, Medical Affairs, Quality, Commercial, and Digital organizations to align Global Patient Safety strategy with corporate objectives and evolving regulatory expectations.
- Championed digital transformation by designing and implementing an executive Power BI Management Oversight Dashboard, providing real-time visibility of operational performance, compliance metrics, resource utilization, and key pharmacovigilance activities across all functional teams to support strategic decision-making.
- Led multiple automation and process optimization initiatives to improve operational efficiency, quality, compliance, and scalability across pharmacovigilance and regulatory writing functions.
- Supported scientific due diligence, safety assessments, and transition planning for product acquisition opportunities, contributing to portfolio expansion and strategic business growth.
Safety Labeling Manager CDS & Signal Detection
Novartis Healthcare
Hyderabad
08.2019 - 03.2021
- Led global safety labeling strategy and Company Core Data Sheet (CCDS) management for approximately 18 development compounds across the Neuroscience, Oncology, and Immunology portfolios, ensuring scientifically robust, compliant, and patient-centric labeling throughout the product lifecycle.
- Successfully led implementation of the FDA Pregnancy and Lactation Labeling Rule (PLLR) across multiple therapeutic areas, collaborating with Global Patient Safety Physicians, Regulatory Affairs, Clinical Development, Clinical Pharmacology, and Medical Affairs to ensure compliant and scientifically sound product labeling.
- Served as the Global Labeling Subject Matter Expert (SME) within the Labeling Working Group, providing strategic scientific recommendations on labeling governance, benefit-risk evaluation, signal impact assessments, and global labeling decisions.
- Led signal evaluation activities by critically assessing clinical trial data, post-marketing safety information, literature, epidemiological evidence, and regulatory intelligence to support timely identification, evaluation, and communication of emerging safety risks.
- Directed the successful implementation of the Hawkeye global labeling surveillance platform, reducing manual website monitoring activities by approximately 40% while improving operational efficiency, regulatory compliance, and inspection readiness.
- Evaluated and provided strategic input into next-generation digital labeling solutions, including DocLabel and DocEvidence platforms, supporting the modernization of global labeling and regulatory document management processes.
- Partnered with Global Patient Safety, Regulatory Affairs, Clinical Development, Medical Affairs, Epidemiology, and affiliate teams to develop and implement global labeling strategies across worldwide markets.
- Supported multiple global regulatory authority inspections, including FDA, MHRA, and HPRA inspections, consistently maintaining inspection readiness and ensuring compliance with global pharmacovigilance and labeling requirements.
- Developed and enhanced global labeling governance frameworks, standard operating procedures (SOPs), and process guidance to improve labeling consistency, operational excellence, and regulatory compliance across global markets.
- Led cross-functional consistency reviews of CCDS, USPI, SmPC, and regional labeling documents, ensuring alignment with evolving scientific evidence, benefit-risk profiles, and global regulatory expectations.
Pharmacovigilance Expert (Medical Safety Expert)
Novartis Healthcare
Hyderabad
02.2017 - 08.2019
- Served as the Medical Safety Expert for multiple investigational products across Neuroscience, Immunology, Ophthalmology, and Cell & Gene Therapy portfolios, providing scientific leadership for safety evaluation, benefit-risk assessment, and risk management throughout clinical development.
- Led cross-functional safety assessments from Target Product Profile (TPP) through regulatory submission, partnering with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, Medical Affairs, Epidemiology, Toxicology, and Clinical Pharmacology to support evidence-based safety decisions.
- Performed blinded and unblinded medical review of serious adverse events (SAEs), adverse events of special interest (AESIs), laboratory abnormalities, protocol deviations, and emerging safety signals to support proactive patient safety management throughout the clinical development lifecycle.
- Served as an active member of Safety Management Teams (SMTs) and Safety Review Teams (SRTs), contributing scientific expertise to benefit-risk evaluations, safety governance, protocol safety discussions, and strategic risk management decisions.
- Provided scientific leadership for the preparation and critical review of Clinical Development Plans (CDPs), study protocols, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and regulatory submission documents, ensuring alignment with evolving safety data and global regulatory expectations.
- Led integrated benefit-risk assessments by evaluating clinical trial data, non-clinical findings, post-marketing safety information, scientific literature, and epidemiological evidence to support governance decisions and regulatory submissions.
- Developed and maintained EU and Global Risk Management Plans (RMPs), including Additional Risk Minimisation Measures (aRMMs), Additional Pharmacovigilance Activities (aPVAs), and pharmacovigilance planning in collaboration with the QPPV Office and cross-functional stakeholders.
- Supported Data Safety Monitoring Board (DSMB) meetings, interim safety analyses, and cross-functional safety governance forums through scientific interpretation of emerging safety data and risk mitigation strategies.
- Contributed to global regulatory submissions, including INDs, IMPDs, CTDs, and Marketing Authorisation Applications (MAAs), supporting health authority responses, inspection readiness, and regulatory compliance throughout the development lifecycle.
- Championed process improvements that enhanced medical safety review workflows, document quality, inspection readiness, and cross-functional collaboration, strengthening operational excellence within Global Patient Safety.
Pharmacovigilance Scientist/ Senior Safety Processing Expert/ Safety Processing Expert
Novartis Healthcare
02.2011 - 02.2017
- Progressed through roles of Safety Processing Expert, Senior Safety Processing Expert, and Pharmacovigilance Scientist based on consistent high performance, technical expertise, and leadership contributions.
- Led global Individual Case Safety Report (ICSR) operations across multiple therapeutic areas, ensuring high-quality case processing and compliance with global pharmacovigilance and regulatory reporting requirements.
- Served as Subject Matter Expert (SME) for Clinical Trial Safety Operations, providing scientific guidance on complex safety cases, quality management, aggregate reporting, and process standardization.
- Authored and reviewed aggregate safety reports, including PSURs and PADERs, supporting global regulatory submissions in accordance with ICH, FDA, and EMA requirements.
- Supported benefit-risk evaluations through Analysis of Similar Events (AOSE), investigator notifications, protocol safety reviews, Argus database configuration reviews, and medical assessment of complex safety cases.
- Led root cause investigations and CAPA implementation, strengthening pharmacovigilance quality systems, inspection readiness, and regulatory compliance.
- Championed digital transformation initiatives by implementing Optical Character Recognition (OCR), Robotic Process Automation (RPA), Auto-Query Generation, Auto-Listedness, and iNarrative solutions, significantly improving operational efficiency, reducing manual effort, and enhancing data quality across pharmacovigilance operations.
- Collaborated with global cross-functional teams to optimize pharmacovigilance processes, develop standard operating procedures, and drive continuous improvement initiatives across clinical trial and post-marketing safety operations.
- Mentored and trained pharmacovigilance professionals, supporting capability development, knowledge transfer, and consistent application of global pharmacovigilance standards.
Education
General Management Progamme -
Indian School of Business (ISB)
01-2019
Master of Science (M.S.) - Regulatory Affairs and Health Policy
Massachusetts College of Pharmacy and Health Sciences
01-2018
Master of Pharmacy - Pharmaceutics
West Bengal University of Technology
01-2010
Leadership Highlights
- 16+ years of progressive leadership experience in Global Patient Safety, Safety Evaluation & Risk Management (SERM), Medical Safety, Regulatory Science, and Clinical Development across leading multinational pharmaceutical organizations.
- Led a Global Patient Safety organization comprising 65 professionals with direct leadership of seven functional managers across SERM, Signal Management, Safety Labeling, Regulatory Writing, and Medical Writing.
- Successfully established a Global Business Services (GBS) operating model by transitioning Pharmacovigilance and Medical Writing functions from Ireland to India, delivering approximately 40% operational cost savings while maintaining quality and regulatory compliance.
- Represented Global Patient Safety during FDA Type B and Type C meetings, global regulatory authority interactions, and multiple health authority inspections, including MHRA, HPRA, Health Canada, SAHPRA, and BfArM.
- Led strategic safety activities across multiple development and marketed products, including benefit-risk assessments, signal management, safety surveillance, aggregate reporting, global labeling strategy, and regulatory submissions.
- Championed enterprise digital transformation initiatives, including Generative AI (DAWN), Power BI executive dashboards, OCR, RPA, Hawkeye, and document automation to improve efficiency, quality, and decision-making.
- Published multiple peer-reviewed scientific articles in Clinical Pharmacology & Therapeutics and Pharmaceutical Medicine, with acknowledged contributions to first-in-human clinical development publications in The Journal of Clinical Pharmacology.
- Graduate of the Indian School of Business (ISB) General Management Programme with demonstrated success in organizational transformation, capability building, people leadership, and operational excellence.
Core Competencies
Global Patient Safety Leadership: Safety Evaluation & Risk Management (SERM) • Benefit-Risk Assessment • Medical Safety • Pharmacovigilance Strategy • Global Safety Governance • Signal Detection & Management • Risk Management Planning (RMP) • Aggregate Safety Reporting
Clinical Development & Regulatory Science: Clinical Development Support • Medical Monitoring • Safety Surveillance • Regulatory Submissions (IND, NDA, BLA, MAA, CTD) • Health Authority Interactions • Safety Labeling (CCDS, USPI, SmPC, PLLR) • Regulatory Writing • Medical Writing
Leadership & Business Management: People Leadership • Organizational Development • Strategic Planning • Budget & Resource Management • Vendor Governance • Global Business Services (GBS) • Cross-functional Leadership • Executive Stakeholder Management • Inspection Readiness
Digital Transformation & Innovation: Generative AI • Document Automation (DAWN) • Power BI • Robotic Process Automation (RPA) • Process Automation • Digital Transformation • Operational Excellence • Lean Six Sigma Black Belt
Global Regulatory & Quality: ICH • FDA • EMA • MHRA • PMDA • Health Canada • SAHPRA • HPRA • GxP Compliance • CAPA • Audit & Inspection Management
Certification
- Lean Six Sigma Black Belt
- Digital Transformation in Healthcare
- Strategic Leadership
Accomplishments
- Led multiple process automation and innovation initiatives including Auto-Query Generation, Auto-Listedness, and INarrative tools, resulting in up to 20% improvement in ICSR processing efficiency and enhanced PV workflow automation.
- Served as project manager for enterprise-wide digital transformation initiatives such as the Asset Connected Ecosystems, Connected Health, and Data & Digital Medical Device programs, aligning safety operations with strategic R&D innovation.
- Played a pivotal role in the GEMS Project and Global Drug Development (GDD) Strategy Dashboard, contributing to delivery excellence, patient-centric outcomes, and improved strategic oversight of safety capabilities.
- Led market research and portfolio strategy assessments for medical device projects, contributing to early pipeline decisions and aligning product development with unmet medical needs.
- Managed project finance, vendor governance, and rapid innovation cycles across strategic initiatives, driving agility, cost efficiency, and stakeholder value within pharmacovigilance systems and global safety infrastructure.
- Recognized with multiple performance awards at Novartis, Aspen Pharmacare, and GSK India for innovation, leadership, and operational excellence in global safety and regulatory roles.
- Nominated for and successfully completed prestigious leadership development programs, including the General Management Programme at Indian School of Business (ISB) and MS in Regulatory Affairs & Health Policy (MCPHS University), sponsored by Novartis.
- Selected for a mini-sabbatical in Global Drug Development, contributing to cross-functional design thinking within the Asset Connected Ecosystems initiative.
- Lean Six Sigma Black Belt certified, with demonstrated ability to lead complex change initiatives and continuous improvement projects in global safety and compliance.
- Co-authored a peer-reviewed publication on challenges in CCDS development and maintenance, in collaboration with a QPPV: Pharmaceut Med. 2020; 34(6): 381-386.
Scientific Publications & Contributions
- Lactation studies across therapeutic areas with emphasis on infectious diseases: A literature review. Clinical Pharmacology & Therapeutics. 2026. Co-author
- Combined oral contraceptive drug-drug interaction studies: Lessons from clinical trials. Clinical Pharmacology & Therapeutics. 2026. Co-author
- Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenance. Pharmaceutical Medicine. 2020. Co-author
- Acknowledged scientific contributor to the first-in-human clinical study publication, “Randomized, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of Novel Antitubercular Drug Candidate GSK2556286 in Healthy Adults.” The Journal of Clinical Pharmacology. 2026.
Professional Leadership & Speaking Engagements
- Panel Speaker, Global Pharmacovigilance & Drug Safety Outsourcing Summit (2025), sharing perspectives on the evolving landscape of Global Patient Safety, Pharmacovigilance, and Global Capability Centers (GCCs).
- Panel Speaker, WHY Summit – Pharmacovigilance Outsourcing (2025), contributing to discussions on operational excellence, capability building, and future-ready pharmacovigilance organizations.
- Scientific contributor to first-in-human clinical development publications supporting innovative therapies and evidence generation.
- Mentor and coach to Patient Safety Scientists, Medical Writers, Regulatory Writers, and Global Patient Safety professionals, supporting talent development, capability building, and leadership succession.
- Active participant in recruitment and leadership interviews, contributing to organizational capability development and high-performing team building.
Awards & Recognition
- Recipient of multiple performance, innovation, and leadership awards at GSK, Aspen Pharmacare, and Novartis for driving operational excellence, scientific leadership, process innovation, and organizational transformation.
- Recognized for leading digital transformation initiatives that improved quality, compliance, and operational efficiency through automation, AI-enabled solutions, and data-driven decision making.
- Selected by Novartis for the prestigious General Management Programme (GMP) at the Indian School of Business (ISB) in recognition of leadership potential and business acumen.
- Selected for the Global Drug Development (GDD) Mini-Sabbatical Programme, contributing to enterprise innovation initiatives, including Asset Connected Ecosystem, Connected Health, Digital Medical Devices, and Global Drug Development strategy.
- Recognized for successfully establishing a Global Business Services (GBS) operating model through the transition of Pharmacovigilance and Medical Writing functions from Ireland to India while delivering significant operational efficiencies.
Timeline
SERM Associate Scientific Director
GSK
06.2023 - Current
Lead-Safety Evaluation & Risk Management, PVO, SLM
Aspen Pharmacare
03.2021 - 06.2023
Safety Labeling Manager CDS & Signal Detection
Novartis Healthcare
08.2019 - 03.2021
Pharmacovigilance Expert (Medical Safety Expert)
Novartis Healthcare
02.2017 - 08.2019
Pharmacovigilance Scientist/ Senior Safety Processing Expert/ Safety Processing Expert
Novartis Healthcare
02.2011 - 02.2017
General Management Progamme -
Indian School of Business (ISB)
Master of Science (M.S.) - Regulatory Affairs and Health Policy
Massachusetts College of Pharmacy and Health Sciences
Master of Pharmacy - Pharmaceutics
West Bengal University of Technology