Juan Camilo Gonzalez

About Juan Camilo Gonzalez

As a strategic and process-oriented leader, I bring extensive experience overseeing pharmacovigilance operations, regulatory affairs, and clinical trials, with a strong focus on compliance and quality systems across product development life cycles. My expertise includes managing regulatory interactions and leading people management initiatives.I am recognized for my strategic vision and problem-solving capabilities, adept at planning and organizing high-stakes projects. My decision-making and negotiation skills are complemented by a proven ability to manage multiple projects simultaneously, meet critical deadlines, and foster collaboration across local, regional, and global teams.I am deeply committed to enhancing compliance and operational efficiency in pharmacovigilance. My approach ensures rigorous adherence to regulatory standards while streamlining processes to improve global operations and maintain the highest standard of quality and compliance.

Experience

1. Head of Pharmacovigilance Operations

   Moderna

   Feb 2023 — Present · Boston, MA, US

   As the Head of Global Pharmacovigilance Operations at Moderna, I lead the strategic direction and management of pharmacovigilance activities worldwide, ensuring the highest standards and strict compliance with all regulatory requirements.Core Responsibilities:Case Safety Reports Management: I manage the processing and handling of individual case safety reports, emphasizing timeliness and accuracy.Quality Management System Maintenance: I continuously enhance our Global PV Quality Management System, adapting to evolving standards.Vendor Management and Inspection Readiness: I oversee external pharmacovigilance vendors, ensuring compliance with Moderna’s quality criteria and maintaining inspection readiness, demonstrating our operational excellence during audits.Innovation and Efficiency: I champion the integration of advanced technologies like automation, Gen AI, and digital tools, streamlining processes, and strengthening compliance and patient safety.Key Accomplishments:Offshoring Efficiency: I successfully offshored case processing operations, significantly boosting productivity and efficiencies globally.Inspection Readiness Strategy: I developed and executed a robust inspection readiness strategy, improving our performance in pharmacovigilance inspections and reinforcing our compliance.Cost-Efficient Vendor Management: I optimized vendor management processes, reducing costs while upholding high quality.Regulatory Compliance Across Geographies: I ensured all operations complied with local, regional, and international regulations, maintaining the integrity of our pharmacovigilance practices.Digital Transformation Leadership: I led a digital transformation initiative, incorporating cutting-edge technologies to enhance efficiency and adaptability, ensuring continuous improvement in patient safety.

Education

• Universitat Pompeu Fabra

  MSc, Master in Health Economics and Pharmacoeconomics

  2005 — 2007

• Duke University

  Business Leadership Program, Merck University

  2011 — 2012

• Universidad Nacional de Colombia

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  1992 — 1998

Skills

• Vaccines
• Oncology
• Clinical Research
• Therapeutic Areas
• Ich-Gcp
• Ctms
• Clinical Development
• Pharmaceutics
• Strategy
• Pharmaceutical Industry
• Pharmacovigilance
• Drug Development
• Gcp
• Clinical Trials
• Market Access
• Health Economics
• CRO
• Regulatory Affairs
• Pharmacoeconomics