Pharmacovigilance Services
Pharmacovigilance is at the core of ensuring patient safety and regulatory compliance in the pharmaceutical and life sciences industries. My Pharmacovigilance Services are designed to help organisations implement, optimise, and maintain robust systems that meet global standards.
Whether you’re starting from scratch or looking to enhance existing processes, I provide tailored solutions to support your pharmacovigilance needs.
System Implementation
A well-designed pharmacovigilance system is essential for monitoring and managing drug safety.
I specialise in the implementation of effective and efficient Pharmacovigilance and Medical Information Systems that align with regulatory requirements.
From initial setup to system integration, I ensure your organisation has the tools and processes needed for seamless pharmacovigilance operations.
Audit & Inspection Readiness
Preparing for audits and inspections can be daunting, but it doesn’t have to be.
I assist organisations in achieving audit and inspection readiness by developing detailed storyboards and playbooks tailored to your specific operations.
These tools help your team understand what to expect, how to respond, and ensure that your systems are fully compliant with regulatory standards.
Process Streamlining
Efficient processes are critical for maintaining compliance and reducing risks.
I help organisations streamline their pharmacovigilance systems by merging multiple platforms and establishing cohesive workflows.
This includes setting up QPPV offices and Local Safety Officer (LSO) systems to ensure smooth operations and better alignment across teams.
Training & Development
Knowledge is power, especially in pharmacovigilance.
I design and deliver comprehensive PV and Good Pharmacovigilance Practice (GVP) training modules and courses to enhance your team’s skills and understanding.
These training programs are customised to meet your organisation’s needs, ensuring your team is equipped to handle the complexities of pharmacovigilance with confidence.
Agreement Harmonisation
Pharmacovigilance agreements are vital for ensuring clear roles, responsibilities, and compliance across partnerships.
I support organisations with business process harmonisation of Pharmacovigilance Agreements, streamlining workflows for better alignment and efficiency.
This ensures that your agreements are not only compliant but also practical and effective in day-to-day operations.
Why choose my Pharmacovigilance Services?
- Expertise: Over 15 years of experience in pharmacovigilance consulting, auditing, and training.
- Custom Solutions: Tailored services to meet your organisation’s unique needs.
- Regulatory Focus: Ensuring compliance with global pharmacovigilance standards.
- Efficiency-Driven: Streamlining processes to save time and reduce risks.
- Collaborative Approach: Working closely with your team to deliver practical, actionable results.
Invest in Stronger Pharmacovigilance Systems
With my Pharmacovigilance Services, your organisation can achieve compliance, efficiency, and improved safety outcomes.
Whether you need help with system implementation, audit preparation, or training, I’m here to support you every step of the way.
Contact me today to discuss how we can strengthen your pharmacovigilance systems and ensure the safety of your products.
Let’s work together to protect patients and meet the highest industry standards!
Can you help with Pharmacovigilance system implementation?
Absolutely! I specialise in implementing effective and efficient Pharmacovigilance & Medical Information Systems to ensure smooth operations.
How could you help us to be audit and inspection ready?
I help organisations get audit-ready with a structured approach that includes:
- Gap Analysis: Identifying compliance risks and addressing gaps.
- Storyboards & Playbooks: Clear guides to streamline audit preparation.
- Mock Audits: Simulating inspections to refine processes and responses.
- Team Training: Preparing staff to confidently handle audits and inspections.
- Documentation Review: Ensuring records and SOPs are complete and compliant.
- Post-Audit Support: Addressing findings and implementing improvements.
What kind of training do you offer?
I create comprehensive PV & GVP Training Modules and courses tailored to enhance your team’s skills and knowledge in Pharmacovigilance.
