About
Moin has over 50 years' experience in the pharmaceutical industry. Pharmacist by education, Moin is one of the most well-known Pharmacovigilance Professionals in Asia-Pacific. He has rich hands-on experience across practically every facet of Industrial Pharmacovigilance, while serving reputed international pharma companies like Sanofi Aventis and Dr. Reddy's, with his last corporate assignment being with Johnson & Johnson as Regional PV QA Director for Asia Pacific. Moin has undergone extensive training in the U.S., Germany, France and Singapore and is a Certified Lead Auditor. As a distinguished PV consultant and auditor, Moin has conducted audits across Asia Pacific, Middle East, CIS Countries, Europe, Africa and Australia, besides helping pharmaceutical companies in establishing PV systems in developing markets, mentoring and training PV Teams.
Professional Experience
Professional Experience
2011 – Present
Founder & CEO
PVCON Consulting Pvt Ltd
Management and execution of global PV audit programmes, GxP Quality Assurance consultancy, CAPA management, inspection readiness support, training programme development, and strategic advice on Quality Management Systems.
2008 – 2011
Regional Director – Asia Pacific, Global Systems Quality Assurance
Johnson & Johnson PRD
Performed system-based audits of J&J global PV/GCP systems and operating companies. Managed PV QA and Clinical QA functions with focus on staff development and compliance across J&J affiliated companies, vendors and marketing partners.
2007 – 2008
Head, Pharmacovigilance
Reliance Clinical Research Services
Oversaw all drug safety surveillance activities related to clinical projects from early phase to Phase IV.
2006 – 2007
Senior Manager, Pharmacovigilance
Dr. Reddy's Laboratories
Set up global PV centre catering to 35 countries including the US & EU. Created PV infrastructure and SOPs for the PV department.
2001 – 2006
Affiliate Pharmacovigilance Head
Sanofi Aventis Pharma Ltd
Safety management during clinical trials and post-marketing safety surveillance for drugs and medical devices.
1976 – 2000
Manager, PV & Epidemiology / Pharma Formulations
Sanofi Aventis (Hoechst Marion Roussel)
Regulatory liaison and licensing, drug and clinical trial registration, external manufacturing management, and tablet manufacturing operations.
Skills
Core Expertise
- Global PV Auditing (Affiliates, Systems, Vendors, Marketing Partners)
- GxP Quality Assurance & Risk-Based Audit Programmes
- EMA GVP, MHRA, US FDA, ICH and Global PV/GCP Regulations
- PSMF Preparation & Quality Review
- Standard Operating Procedure Development
- Regulatory Inspection Readiness & CAPA Management
- Corporate PV Training Programme Development
Achievements
Qualifications & Recognition
- Adjunct Professor — Jamia Hamdard University, Delhi
- Lead, South Asia Chapter — International Society of Pharmacovigilance (ISoP)
- Pharma Ratan Award — Lifetime Achievement in Pharmacy from DCGI
- PV Consultant appointed by Botswana Regulatory Authority (BoMRA)
- Program Chair & Member — DIA India PV Conferences (11+ years)
- Certified Lead Auditor — Trained in USA, Germany, France & Singapore
- Course Director — PG Diploma in Pharmacovigilance, Bombay College of Pharmacy
- Trainer — Uppsala Monitoring Centre (UMC) Asia Pacific PV Workshop
- Trainer — Pharmacovigilance Program of India (PvPI) for DCGI & CDSCO
Ready to Work With Our Team?
Connect with our pharmacovigilance experts and discover how PVCON can support your regulatory compliance and drug safety operations.
Get in Touch