About
Nazrul has over 24 years' experience within Pharmaceutical Research & Development, Quality Assurance, Quality Management Systems, clinical drug development, post-marketing regulatory affairs, drug safety/pharmacovigilance, and regulatory compliance. He has extensive global regulatory and PV QA auditing experience covering Local Operating Companies, Co-Development Partners, CROs, GxP service providers, and computer systems validation. He has a proven track record in fully managing and hosting numerous health authority PV and GCP inspections. Nazrul is actively involved in providing audit training within industry, a member of the Research Quality Assurance (RQA) and Drug Information Association (DIA), a tutor on the RQA Practical PV Auditing Course, and a co-author of the RQA PV Auditing Handbook.
Professional Experience
Professional Experience
2017 – Present
Independent GxP Auditor & Consultant Lead Auditor
PVCON Consulting
GVP audits covering Affiliates, Systems, Business Partners, and Vendors & GMP,GDP, GCP and CSV audit services. Additional support with SOP development, QMS consultancy, Gap analysis, Inspection readiness, GVP risk assessment, and Audit program development.
2018 – 2022
PV Auditing & QA
Bristol Myers Squibb/ Seagen Inc./ Johnson & Johnson Ethicon
PV auditing, gGap analysis, PV Auditor training, dDevelopment of procedures and rRisk-based PV audit programs.
2014 – 2015
Director, Global LOC QA, R&D GCP & GVP QA
Takeda Pharmaceuticals Limited Europe
Global PV Lead for Local Operating Company audits including GCP and QMS QA activities. Oversight of regional PV, GCP and QMS activities and external QA service providers.
2014 & 2015 – 2018
QA Program Manager (Janssen R&D, J&J Family)
Independent Consultant
Performed Janssen R&D Quality & Compliance QA PV audits. Coached, mentored and developed iInternal auditors’ coaching, development and mentoring. Delivered Training on PV topics and systems.
2012 – 2013
Associate Director of Pharmacovigilance
Zigzag Associates Ltd, UK
Management of PV systems audit programmes, regulatory inspection facilitation, CAPA planning, QMS development, and line management of personnel.
2006 – 2012
Program Manager, Global System Quality Assurance
Johnson & Johnson PRD, UK
System-based audits of J&J global PV/GCP systems. Managed UK MHRA and US FDA PV and GCP inspections (announced and unannounced). Supported licensing and due diligence activities.
2001 – 2005
Senior Pharmacovigilance Scientist
MHRA (Medicines & Healthcare Regulatory Products Agency), UK
Review of ICSRs for compliance and signal detection, PSUR review, safety variation assessments, oversight of UK ADR Regional Monitoring Centres, and presentations at MHRA Sub-Committee on Safety of Medicines.
Skills
Core Expertise
- EU/US FDA and Global PV & GCP Regulations
- PV & GCP QA Compliance and Risk-Based Strategies
- EU PV Legislation & GVP Module Implementation
- PSMF Preparation & Quality Review
- Global LOC/Affiliate PV Audits (EU, Americas, Middle East, Africa, Asia Pacific, Australia)
- Health Authority PV & GCP Inspections (MHRA, FDA, EMA)
- QA Management Strategies & Risk-Based Audit Programmes
- SOP Development & Quality Management Systems
- GMP, GDP, and Computer Systems Validation Auditing
Achievements
Qualifications & Recognition
- MSc Clinical Pharmacology — University of Surrey, UK
- HND Pharmacology (Distinction) — University of East London, UK
- Member — Research Quality Assurance (RQA)
- Member — Drug Information Association (DIA)
- Co-author — RQA PV Auditing Handbook
- Tutor — RQA Practical PV Auditing Course (Madingley Hall, Cambridge, UK)
- Speaker — DIA Conference India, BARQA Forums, UK ePharma Day
- Delegate — MHRA Pharmacovigilance Symposium, ISOP Conferences
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