Pharmacovigilance systems must be robust, compliant, and capable of supporting both clinical development and post-marketing activities.
I provide pharmacovigilance oversight and audit support in collaboration with an established specialist pharmacovigilance organization, ensuring systems and processes meet global regulatory expectations.
This model provides access to deep pharmacovigilance expertise while maintaining a single, experienced point of contact for quality and compliance oversight.
This includes:
• Oversight and assessment of pharmacovigilance systems and processes
• Safety system audits and vendor qualification
• Gap analyses aligned to global pharmacovigilance regulations and guidance
• Support for remediation activities and CAPA development
• Integration of pharmacovigilance oversight within broader quality systems
Services are delivered in collaboration with Perspective Pharmacovigilance (PPV), a specialist pharmacovigilance organization.
Click here to read more about PPV, and engage me through their organization.
