Brian Edwards

Senior pharmacovigilance consultant with 25+ years of experience across regulatory authority, CRO, and pharmaceutical environments. Leads high-impact GVP audits, inspection readiness, and compliance strategy across EU and global frameworks. Trusted advisor to sponsors and vendors, identifying critical gaps, directing CAPA remediation, and strengthening pharmacovigilance systems under regulatory scrutiny.

Brings proven expertise in QPPV oversight, risk management, and system optimization, delivering measurable compliance outcomes across global programs.

Managing Director | Senior Pharmacovigilance Consultant at HUSOTERIA LTD (2020-01 – Present)

• Lead end-to-end GVP audits across sponsor organizations and pharmacovigilance vendors, ensuring alignment with EU GVP Modules, FDA requirements, and global regulatory standards.
• Identify critical compliance gaps and deliver audit reports that directly support successful inspection readiness and regulatory outcomes.
• Advise senior stakeholders on inspection readiness strategies, strengthening pharmacovigilance systems and reducing regulatory risk exposure.
• Direct CAPA development, EU and UK QPPV oversight, UK QPPV role, and pharmacovigilance system optimization to deliver sustained compliance across global programs.

Principal Consultant, Pharmacovigilance & Drug Safety at NDA REGULATORY SCIENCE LTD (2007-01 – 2021-12)

• Led pharmacovigilance audits across multinational pharmaceutical and device companies and vendors, ensuring compliance with EU and US regulatory frameworks.
• Advised organizations on inspection readiness, including those under regulatory scrutiny, enabling successful compliance outcomes.
• Designed and implemented compliant pharmacovigilance systems across multiple therapeutic areas, strengthening global safety infrastructures.
• EU QPPV for multiple clients
• Delivered over 30 Risk Management Plans and provided strategic regulatory input, including agency interactions and audit readiness training.

Deputy Qualified Person for Pharmacovigilance and Authorized Representative at JOHNSON & JOHNSON (JANSSEN) (2005-01 – 2007-12)

• Oversaw compliance of European pharmacovigilance systems for marketed products, ensuring alignment with evolving EU regulatory requirements.
• Supported enhancement and standardisation of pharmacovigilance infrastructure, strengthening system integrity across regional operations.
• Partnered with senior stakeholders to reinforce governance, oversight, and execution of pharmacovigilance obligations.
• Delivered training and capability development across global pharmacovigilance teams to drive consistent compliance standards.

Senior Medical Director, Global Pharmacovigilance at PAREXEL INTERNATIONAL (1999-01 – 2005-12)

• Led global pharmacovigilance strategy across clinical development and post-marketing programs for international clients.
• Directed inspection readiness and compliance initiatives, supporting organizations in achieving FDA and EU regulatory approval standards.
• Advised on risk-benefit strategy and crisis management, influencing safety decisions across complex product portfolios.
• Provided senior-level pharmacovigilance consultancy, strengthening regulatory compliance frameworks and operational execution.

Senior Medical Assessor, Pharmacovigilance Assessment Group at MEDICINES CONTROL AGENCY (UK) (1994-01 – 1999-12)

• Led regulatory evaluation of drug safety data, informing national pharmacovigilance decisions and risk assessments.
• Produced detailed assessment reports for UK and European regulatory bodies, supporting licensing and safety actions.
• Contributed to high-impact safety reviews and regulatory decision-making across a range of therapeutic areas.
• Supported development and implementation of pharmacovigilance policies, strengthening national safety surveillance frameworks.

Doctor of Medicine in Medicine – University of Manchester

Member of the Royal College of Physicians in Medicine – United Kingdom

Bachelor of Medicine, Bachelor of Surgery in Medicine

Bachelor of Science in Pathology (Hons)