Zaheeruddin Mohammad
Bengaluru
Summary
Seasoned Pharmacovigilance and Quality Compliance professional with over 17 years of global experience in the pharmaceutical and biotech industries. Expertise includes PV operations, PV compliance, vendor management, GxP audit readiness, digital QMS implementation, RCA/CAPA management, and regulatory safety governance. Proven leadership in managing PV Alliance compliance and recognized for excellence in Audits and inspection management and digital transformation at GSK and Novartis. Certified PMP (PMI) and Lean Six Sigma Green Belt, with a consistent track record of building audits and inspection-ready quality systems.
Overview
18
18
years of professional experience
Work History
Sr.SDEA Specialist I / Sr.PVASC Compliance Lead I
GlaxoSmithKline (GSK)
Bengaluru
05.2025 - Current
Sr.SDEA Specialist II /Sr.PVASC Compliance Lead II
GLAXOSMITHKLINE (GSK)
Bengaluru
10.2021 - 04.2025
- Deputized Associate Director to lead global PV compliance and quality oversight, managing end-to-end deviation and CAPA lifecycle within the digital QMS (VQMS), aligned with ALCOA+ principles.
- Spearheaded root cause analysis and corrective/preventive action (RCA/CAPA) governance, driving timely resolution of quality incidents and systemic issues through data-driven investigations.
- Managed quality incidents/events across cross-functional teams, ensuring thorough documentation, risk mitigation, and compliance with regulatory timelines.
- Reduced compliance reporting turnaround time by 70% using Lean Six Sigma methodology, contributing to overall process efficiency and improved quality outcomes.
- Led global GxP inspection readiness activities, conducted mock audits for the team.
- Oversaw vendor performance using KPI dashboards, risk registers, and lessons learned frameworks; enabled continuous improvement through proactive monitoring and feedback loops.
- Delivered global stakeholder training, SOP revisions, and knowledge sharing sessions to strengthen quality culture and harmonize compliance practices.
- Project-managed Single Vendor Model implementation.
- Led change management during Haleon’s demerger, ensuring seamless transition and sustained compliance in post-demerger operations.
- Proposed and implemented a new framework for managing undefined non-compliance scenarios.
- Coordinated the intake, triage, and compliance of periodic safety reports (PBRER, PSUR, DSUR, CSR, RMP, CCSI, PSRIs, and signal tracking) as per PV Agreements (PVAs).
Vigilance Compliance Excellence Manager
Novartis Healthcare Pvt. Ltd.
Hyderabad
09.2020 - 10.2021
PV Compliance & Quality Manager
Novartis Healthcare Pvt. Ltd.
Hyderabad
04.2020 - 08.2020
- Acted as Deputy Head for Vigilance Compliance Excellence, providing strategic oversight and leadership in global PV compliance with over 95 license partners and more than 140 PV agreements.
- Spearheaded deviations and CAPA management processes, including RCA investigations and closure tracking within electronic Quality Management Systems (AQWA), ensuring alignment with ALCOA+ principles.
- Authoring and reviewing of weekly 5 Key HA reports, and monthly ICSR HA compliance reports to monitor KPIs and identify non-compliance trends, enabling data-driven process improvements.
- Monitor the LP and HA compliance for aggregate reports (PBRER/DSUR) and labeling documents, investigator notifications, literature review metrics, etc.
- Led internal audits, supported global health authority inspections, and authored audit readiness frameworks to strengthen inspection preparedness across GxP domains.
- Created and maintained real-time dashboards for metrics related to operations and PSMF, to enhance transparency in PV operations and decision-making at leadership levels.
- Collaborated with IT and functional teams to optimize QMS functionalities, such as automated query handling and deviation documentation workflows.
- Facilitated cross-functional stakeholder training and continuous improvement programs to strengthen CAPA practices and quality culture.
- Provided quality oversight and mentoring for global teams, fostering collaboration across R&D, Safety, and partner functions to ensure regulatory compliance and operational excellence.Oversaw compliance metrics for inbound, outbound, and reconciliations across 95+ license partners and 140+ PV agreements.
- Authored comprehensive reports to monitor ICSR HA compliance on a weekly and monthly basis.
- Conducted investigations to identify root causes of non-compliance.
- Oversaw deviation handling within Quality Management System (AQWA).
- Facilitated effective communication across various functional and operational levels with partners and ESPs.
PV Compliance & Quality Expert
Novartis Healthcare Pvt. Ltd.
Hyderabad
07.2018 - 03.2020
- Executed a risk assessment to evaluate LP and vendor performance effectiveness.
- Authored multiple PV compliance and quality reports, including 5 Key HAs compliance reports, overall HA monthly reports, literature monthly reports, quality report with trend analysis, deactivation metrics, etc.
- Reviewed and managed RCA/CAPAs, ensuring effective collation from internal and external stakeholders.
- Expert in performing detailed investigations to address audits and inspections findings by using lean six sigma tools (5 Whys analysis, Pareto analysis, Ishikawa diagram, and FMEA) to identify the right root cause and develop robust corrective and preventive actions.
Alliance Compliance Expert
Novartis Healthcare Pvt. Ltd.
Hyderabad
01.2017 - 07.2018
- Authored compliance and reconciliation reports to ensure adherence to Pharmacovigilance Agreements (PVAs) with LPs.
- Managed RCA/CAPA processes with collaboration with internal stakeholder, ESPs, LPs and timely escalation to leadership about the compliance issues identified.
- Monitored database configurations and ensure PV Agreements are periodically updated.
- Improved cross-functional engagement and organizational efficiency through process and technology enhancements (I-Track).
Senior Safety Processing Expert
Novartis Healthcare Pvt. Ltd.
Hyderabad
04.2015 - 12.2016
- Managed ICSR quality and compliance metrics and conducted trend analysis to improve quality in handling priority products.
- Managed the workload distribution across 50 associates, including internal and 03 vendors.
- Managed compliance and quality issues through effective monitoring and investigation processes.
- Acted as liaison with License Partners and ESPs for queries, quality, and compliance issues.
- Contributed to key projects like Literature CAPA, Duplicate Search, M-Code Correction, and PSUR.
Safety Processing Expert
Novartis Healthcare Pvt. Ltd.
Hyderabad
05.2011 - 03.2015
- End-to-End ICSR Case processing activities with excellent productivity and quality.
- Screen and review of literature articles by using LiSA application.
- Developed, contributed, and maintained procedural documents and MAP processes/PGD/SGD/ Configured of clinical studies in Argus database.
- Lead for 2 priority products to improve the compliance and quality in case processing.
Clinical Research Coordinator
Mediciti Research Cell, Mediciti Hospital
Hyderabad
09.2007 - 04.2011
- Assisted in patient recruitment, screening, and medical history collection for clinical trials.
- Performed protocol-defined tasks and ensured accurate CRF/e-CRF documentation.
- Oversaw clinical supplies and managed Ethics Committee submissions and reporting.
- Coordinated Phase II–IV trials, primarily targeting cardiac and diabetic conditions.
Education
PMP (PMI) Certified - Project Management
Project Management Institute
United States05-2025
Lean Six Sigma Green Belt (LSSGB) -
Exemplar Global
08.2020
PGCBM - Business Management
XLRI
Jamshedpur07.2018
M.Sc. - Biochemistry
Acharya Nagarjuna University
05.2005
Skills
- GVP/GCP Compliance & Quality Management
- Management of quality incidents, quality events, RCA, and CAPAs in VQMS/AQWA
- Global PV Alliance (SDEA/PVA) compliance
- KPI monitoring and trend analysis
- Vendor oversight
- LSSGB (Exemplar Global) and PMP (PMI) certified
- Cross-functional stakeholder engagement
- Training and mentorship
- Cross-functional stakeholder engagement
- Risk assessment
- Training champion
- Quality champion
- Power BI dashboard
- Cross-functional Stakeholder Engagement
- Lean Six Sigma & Project Management (PMP)
- Training & Mentorship
Accomplishments
- Global Employee Recognition - Gold Award for the transformation of compliance checks for Local PVAs and Quality Improvement sessions and workshops conducted for GSP-PVASC with innovative ideas.
- Global Employee Recognition - Silver Award for going above and beyond for Single Vendor Model project.
- Embrace operational excellence every day in the Star Award (IMPACT) program in Q4 2020 at Novartis.
- Star Award (IMPACT) for supporting ICSR submission compliance report during Argus 8 period in Q3 2020 (Novartis).
- Power BI Champion and well versed with MS Office suite.
- Star Award (IMPACT) for supporting ICSR submission compliance report during Argus 8 period in Q3 2020 (Novartis).
- Power BI Champion and well versed with MS Office suite.
Projects
Transformation of compliance checks for Local PVASC
Project Digital Fluency at GSK Single Vendor Model Project at GSK.
Project ERoCC (Early Release Of Compliance Checks) at GSK
Mock Audits for PVASC Team at GSK
Project Compaq at Novartis
Predictive modeling and forecasting project for LP compliance reports at Novartis
Timeline
Sr.SDEA Specialist I / Sr.PVASC Compliance Lead I
GlaxoSmithKline (GSK)
05.2025 - Current
Sr.SDEA Specialist II /Sr.PVASC Compliance Lead II
GLAXOSMITHKLINE (GSK)
10.2021 - 04.2025
Vigilance Compliance Excellence Manager
Novartis Healthcare Pvt. Ltd.
09.2020 - 10.2021
PV Compliance & Quality Manager
Novartis Healthcare Pvt. Ltd.
04.2020 - 08.2020
PV Compliance & Quality Expert
Novartis Healthcare Pvt. Ltd.
07.2018 - 03.2020
Alliance Compliance Expert
Novartis Healthcare Pvt. Ltd.
01.2017 - 07.2018
Senior Safety Processing Expert
Novartis Healthcare Pvt. Ltd.
04.2015 - 12.2016
Safety Processing Expert
Novartis Healthcare Pvt. Ltd.
05.2011 - 03.2015
Clinical Research Coordinator
Mediciti Research Cell, Mediciti Hospital
09.2007 - 04.2011
PMP (PMI) Certified - Project Management
Project Management Institute
Lean Six Sigma Green Belt (LSSGB) -
Exemplar Global
PGCBM - Business Management
XLRI
M.Sc. - Biochemistry
Acharya Nagarjuna University
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